510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Bio-Rad

MARNES-LA-COQUETTE Ile-de-France, FR

BIO-RAD appears in FDA device records in MARNES-LA-COQUETTE Ile-de-France, FR. FDA records list 319 510(k) clearances between and , 3 PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
319
PMA records
3
Recall records
0
Registered establishments
2

510(k) clearance history

Showing 50 of 319

FDA records hold 319 510(k) clearances for Bio-Rad between 1976 and 2017. The busiest year on record is 1998, with 33. The most recent is 2017, with 1.

Clearances by year, as a table
510(k) clearance decisions for Bio-Rad, by decision year
YearClearances
19764
19773
19783
197911
19804
19817
19824
19837
19842
19855
198611
19877
198821
198910
19909
19914
19929
199316
19947
199511
199610
199710
199833
199929
200015
20018
200213
200323
20048
20055
20061
20071
20083
20101
20112
20121
20171
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K171061MRSASelect IIJSOSubstantially Equivalent
K122187VRESELECT CULTURE MEDIUMJSOSubstantially Equivalent
K103684VRESELECT CULTURE MEDIUMJSOSubstantially Equivalent
K093678PLATELIA ASPERGILLUS EIA MODEL 62793NOMSubstantially Equivalent
K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSJSOSubstantially Equivalent
K081362PLATELIA LYME IGMLSRSubstantially Equivalent
K081212MRSASELECT - EXTENDED INCUBATIONJSOSubstantially Equivalent
K080012PLATELIA LYME IGG ASSAYLSRSubstantially Equivalent
K070361MRSASELECTJSOSubstantially Equivalent
K060641PLATELIA ASPERGILLUS EIA, MODEL 62793NOMSubstantially Equivalent
K052838LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4GGMSubstantially Equivalent
K052053LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAKDIFSubstantially Equivalent
K050537LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUSJJYSubstantially Equivalent
K050536QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROLJJYSubstantially Equivalent
K043208LIQUID ASSAYED MULTIQUAL CONTROLJJYSubstantially Equivalent
K042865LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)DIFSubstantially Equivalent
K042836LIQUICHEK RETICULOCYTE CONTROL (A)JPKSubstantially Equivalent
K042815QUEST TUMOR MARKER CONTROL, MODEL 955JJYSubstantially Equivalent
K042837LIQUICHEK ELEVATED CRP CONTROLJJXSubstantially Equivalent
K042324LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5JJYSubstantially Equivalent
K041561LIQUICHEK WHOLE BLOOD VOLATILES CONTROLDIFSubstantially Equivalent
K041457LIQUICHEK HEMATOLOGY CONTROL (A)JPKSubstantially Equivalent
K040275LYPHOCHEK HEMOSTASIS CONTROLGGNSubstantially Equivalent
K033404LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)DIFSubstantially Equivalent
K033366LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455DIFSubstantially Equivalent
K033387QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945JJYSubstantially Equivalent
K032611LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743GGNSubstantially Equivalent
K032017LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3GGNSubstantially Equivalent
K031231LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSISJJWSubstantially Equivalent
K023857PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794NOMSubstantially Equivalent
K030182LIQUICHEK D-DIMER CONTROL, MODEL 356, 357GGNSubstantially Equivalent
K024232LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113LKJSubstantially Equivalent
K024220LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130DHNSubstantially Equivalent
K024218LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114LKJSubstantially Equivalent
K024230LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131DHNSubstantially Equivalent
K024229LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111DHNSubstantially Equivalent
K024227LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127DHNSubstantially Equivalent
K024225LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119DHNSubstantially Equivalent
K024224LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129DHNSubstantially Equivalent
K024222LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112DHNSubstantially Equivalent
K024221LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118DHNSubstantially Equivalent
K024219LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115LKPSubstantially Equivalent
K024217LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108DHNSubstantially Equivalent
K024231LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118DHNSubstantially Equivalent
K024223LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116LKJSubstantially Equivalent
K024226LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116LKJSubstantially Equivalent
K013839BIO-RAD PLATELIA TOXO IGG TMBLGDSubstantially Equivalent
K013837BIO-RAD PLATELIA TOXO IGM TMBLGDSubstantially Equivalent
K022991LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596JJYSubstantially Equivalent
K022707LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439DIFSubstantially Equivalent

Registered establishments

FDA registered establishments for Bio-Rad, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30028896273002889627BIO-RAD3 BOULEVARD RAYMOND POINCARE, MARNES-LA-COQUETTE Ile-de-France 92430 FR2026
80230603003992026BIO-RADROUTE DE CASSEL, STEENVOORDE Nord 59114 FR2026and 7 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain