Bio-Rad
FDA 510(k) medical device clearances.
Top product codes for Bio-Rad
Recent clearances by Bio-Rad
1–100 of 319- K171061 — MRSASelect II
- K122187 — VRESELECT CULTURE MEDIUM
- K103684 — VRESELECT CULTURE MEDIUM
- K093678 — PLATELIA ASPERGILLUS EIA MODEL 62793
- K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS
- K081362 — PLATELIA LYME IGM
- K081212 — MRSASELECT - EXTENDED INCUBATION
- K080012 — PLATELIA LYME IGG ASSAY
- K070361 — MRSASELECT
- K060641 — PLATELIA ASPERGILLUS EIA, MODEL 62793
- K052838 — LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
- K052053 — LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK
- K050537 — LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS
- K050536 — QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL
- K043208 — LIQUID ASSAYED MULTIQUAL CONTROL
- K042865 — LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)
- K042815 — QUEST TUMOR MARKER CONTROL, MODEL 955
- K042836 — LIQUICHEK RETICULOCYTE CONTROL (A)
- K042837 — LIQUICHEK ELEVATED CRP CONTROL
- K042324 — LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5
- K041561 — LIQUICHEK WHOLE BLOOD VOLATILES CONTROL
- K041457 — LIQUICHEK HEMATOLOGY CONTROL (A)
- K040275 — LYPHOCHEK HEMOSTASIS CONTROL
- K033366 — LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455
- K033404 — LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)
- K033387 — QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
- K032611 — LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743
- K032017 — LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3
- K031231 — LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS
- K023857 — PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794
- K030182 — LIQUICHEK D-DIMER CONTROL, MODEL 356, 357
- K024218 — LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114
- K024220 — LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130
- K024232 — LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113
- K024217 — LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108
- K024219 — LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115
- K024221 — LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118
- K024222 — LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112
- K024224 — LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129
- K024225 — LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119
- K024227 — LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127
- K024229 — LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111
- K024230 — LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131
- K024223 — LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116
- K024231 — LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118
- K024226 — LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116
- K013837 — BIO-RAD PLATELIA TOXO IGM TMB
- K013839 — BIO-RAD PLATELIA TOXO IGG TMB
- K022991 — LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596
- K022707 — LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439
- K022525 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509
- K022529 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669
- K021384 — LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444
- K021411 — LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463
- K021414 — LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467
- K021415 — LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469
- K021498 — LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
- K020610 — LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529
- K020878 — LYPHOCHEK HEMOSTASIS, MODELS 798, 799
- K012722 — LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783
- K012741 — LIQUICHEK TDM CONTROL
- K012656 — LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
- K012513 — LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642
- K011853 — ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10
- K011867 — LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700; LEVEL 3 #981800
- K011579 — LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580
- K011494 — LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL
- K003280 — VARIANT II TOTAL GHB
- K003239 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506
- K003242 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623
- K003030 — LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
- K002865 — LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578
- K002866 — LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574
- K002460 — LIQUICHEK LIPIDS CONTROL, MODEL 641, 642
- K002535 — LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513
- K002536 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER)
- K002120 — LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573
- K002196 — LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483
- K001373 — LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363
- K000875 — ASSAYED QCS 1,2, CAT. NOS. 970200, 970500
- K000874 — URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100
- K992781 — ARCHITECH AFP MASTERCHECK, MODEL 6C01-05
- K993107 — BIO-RAD HOMOCYSTEINE BY HPLC
- K992741 — LYPHOCHEK ANEMIA CONTROL, MODEL 500
- K993536 — BIO-RAD CODA NEONATAL GALT ASSAY
- K992172 — LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580
- K992550 — LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3
- K991127 — VARIANT II B-THALASSEMIA
- K990610 — ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10
- K990858 — LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789
- K990928 — LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405
- K990827 — MICROPLATE NEONATAL GALT ASSAY
- K990587 — ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01
- K990888 — MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752
- K990424 — ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01
- K990608 — ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05
- K990393 — ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05
- K990317 — ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01
- K990394 — ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02
- K990391 — ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01
Data sourced from openFDA. This site is unofficial and independent of the FDA.