Beckman Coulter, Inc.
Beckman Coulter, Inc. holds FDA 510(k) medical device clearances, first cleared 1993, most recent 2026, with 334 FDA device recalls on record.
Clearances by Beckman Coulter, Inc. — page 2
101–200 of 270- K100607 — COULTER 4C-EX 300 CELL CONTROL
- K100010 — HDL CHOLESTEROL (HDLX) ASSAY
- K092505 — BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
- K093458 — SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
- K091846 — SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
- K083867 — ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND
- K091742 — SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
- K091153 — SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291
- K090588 — POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210
- K082251 — SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100
- K080481 — ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS
- K082162 — COULTER BODY FLUID CONTROL
- K081822 — COULTER 6C CELL CONTROL, MODELS 628027 & A59925
- K081641 — COULTER LIN-X LINEARITY CONTROL
- K081930 — UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
- K081526 — FLOWCARE TLG REAGENT
- K080634 — ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495
- K080812 — HEMOCCULT ICT
- K080869 — ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC
- K080166 — ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545
- K072612 — ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647
- K071681 — CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554
- K071002 — IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT
- K071277 — SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
- K071280 — SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
- K071283 — SYNCHRON SYSTEMS CREATININE REAGENT
- K070626 — SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT
- K070144 — INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS
- K052223 — ACCESS EPO ASSAY
- K062516 — ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)
- K061616 — COULTER LH 780 HEMATOLOGY ANALYZER
- K061190 — ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953
- K061574 — COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
- K061382 — ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227
- K061282 — ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585
- K061064 — COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503
- K060935 — SYNCHRON SYSTEMS CREATININE (CREA) REAGENT
- K053612 — DRI-STAT ACID PHOSPHATASE REAGENT
- K060774 — FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208
- K060464 — COULTER 5C CELL CONTROL
- K060256 — UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
- K060130 — IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
- K053090 — DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
- K052905 — MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER
- K052082 — FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
- K051122 — ITAG MHC TETRAMER CMV ASSAY
- K051307 — SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT
- K050119 — PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT
- K043556 — SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT
- K050057 — COULTER LH 750 HEMATOLOGY ANALYZER
- K050202 — CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
- K043215 — FLOWCARE PLG CD4 REAGENT
- K042459 — SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
- K042291 — UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS
- K042724 — MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER
- K042173 — COULTER A T 5DIFF CAP PIERCE (CP)
- K042651 — FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
- K042195 — SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747
- K042281 — MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY
- K041643 — SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT
- K040767 — SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT
- K040181 — ACCESS DHEA-S REAGENT ASSAY
- K033036 — BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647
- K033038 — GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688
- K033603 — INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999
- K032342 — COULTER LH 750 HEMATOLOGY ANALYZER
- K032287 — MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
- K032000 — COULTER LH 500 HEMATOLOGY ANALYZER
- K032162 — ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY
- K032035 — SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI
- K032013 — COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
- K031870 — SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
- K031606 — ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
- K031506 — ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY
- K030828 — TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)
- K031270 — ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS
- K031269 — ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- K031297 — ACCESS OV MONITOR ASSAY
- K031002 — SYNCHRON SYSTEMS OPIATE REAGENT
- K030606 — COULTER LH 750 BODY FLUIDS APPLICATION
- K030291 — COULTER ACT 5DIFF AUTOLOADER (AL)
- K030408 — CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A
- K024210 — IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR
- K023764 — UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
- K030012 — CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372
- K023480 — ACCESS TOTAL BHCG
- K023597 — ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
- K023369 — ACCESS TOTAL T4 ASSAY
- K023093 — ACCESS HYPERSENSITIVE HTSH ASSAY
- K023048 — MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
- K023049 — SYNCHRON LX I 725 CLINICAL SYSTEM
- K021814 — ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345
- K022161 — MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
- K021572 — SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR
- K021229 — MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244
- K021150 — COULTER CELLPREP
- K020521 — MODIFICATION TO VIGIL LIPID CONTROL
- K014173 — SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
- K014103 — SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR
- K013978 — SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.