Beckman Coulter, Inc.
FDA 510(k) medical device clearances.
Clearances by Beckman Coulter, Inc. — page 3
201–270 of 270- K014034 — MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
- K013842 — IMMUNO-TROL LOW CELLS
- K013076 — SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR
- K012900 — ACCESS UNCONJUGATED ESTRIOL CALIBRATORS
- K013235 — MODIFICATION TO SYNCHRON CONTROL
- K012208 — ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895
- K010748 — SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
- K011342 — COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
- K003259 — ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479
- K011465 — SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
- K010429 — ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345
- K010597 — SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT
- K011213 — MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
- K010696 — BECKMAN COULTER DNASE B CALIBRATOR
- K010765 — COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526
- K010693 — VIGIL DNASE B CONTROL
- K010236 — IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT
- K010428 — ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349
- K010358 — VIGIL SEROLOGY CONTROL LEVEL C
- K010064 — 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
- K010066 — 5C-ES CELL CONTROL, MODELS 7547191, 7547192
- K003196 — SYNCHRON SYSTEMS AMMONIA REAGENT
- K003488 — SYNCHRON CONTROL
- K003098 — ACCESS ULTRASENSITIVE HGH CALIBRATORS
- K002905 — ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
- K002799 — PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100
- K002453 — ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479
- K001935 — ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565
- K001458 — SYNCHRON CONTROL
- K000121 — IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB
- K000606 — SYNCHRON SYSTEMS AMPHETAMINE REAGENT
- K000494 — SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
- K000410 — SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
- K994278 — ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
- K000716 — ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER
- K000196 — ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316
- K000331 — SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR
- K994168 — SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR
- K994169 — SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR
- K993547 — BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB
- K993549 — BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR
- K994200 — ACCESS HYBRITECH PSA QC, MODEL 37209
- K994277 — ACCESS OSTASE QC
- K994439 — ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306
- K994325 — SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR
- K993954 — SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS
- K993210 — ACCESS HYBRITECH FREE PSA QC, MODEL 37219
- K993023 — SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS
- K993473 — SYNCHRON SYSTEMS DRUG CALIBRATOR 2
- K993022 — SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS
- K990704 — ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT
- K984152 — SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT
- K984402 — SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT
- K983747 — SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II
- K984014 — SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
- K983640 — SYNCHRON SYSTEMS LIPID CALIBRATOR
- K983340 — IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR
- K983895 — IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT
- K983151 — IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT
- K983209 — SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I
- K983709 — SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1
- K982935 — SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR
- K981985 — ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209
- K982224 — VIGIL PROTEIN CONTROL
- K982022 — VIGIL HEMOGLOBIN (HBALC) CONTROLS
- K981638 — IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
- K981864 — ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219
- K955434 — ACCESS FOLATE ASSAY (MODIFICATION)
- K943149 — ACCESS RED BLOOD CELL FOLATE ASSAY
- K932887 — ACCESS FOLATE ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.