510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Biomerieux Vitek, Inc.

Hazelwood, MO, US

Biomerieux Vitek, Inc. appears in FDA device records in Hazelwood, MO. FDA records list 49 510(k) clearances between and , 131 PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
49
PMA records
131
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 49 510(k) clearances for Biomerieux Vitek, Inc. between 1992 and 1998. The busiest year on record is 1993, with 18. The most recent is 1998, with 1.

Clearances by year, as a table
510(k) clearance decisions for Biomerieux Vitek, Inc., by decision year
YearClearances
19927
199318
199410
19955
19965
19973
19981
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K973819VIDAS D-DIMER (DD) ASSAYDAPSubstantially Equivalent
K972895VIDAS ROTAVIRUS (RTV) ASSAYLIQSubstantially Equivalent
K965092VIDAS ROTAVIRUS ASSAYLIQSubstantially Equivalent
K964887VIDAS C. DIFFICILE TOXIN A II ASSAYLLHSubstantially Equivalent
K955627VIDAS CHLAMYDIA BLOCKING ASSAYLJCSubstantially Equivalent
K962609GRAM NEGATIVE IDENTIFICATION PLUS CARDLRHSubstantially Equivalent
K962549VIDAS CREATINE KINASE MB ASSAY 30-421JHXSubstantially Equivalent
K952095VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)LQLSubstantially Equivalent
K955647VIDAS ESTRADIOL II (E2II) ASSAYCHPSubstantially Equivalent
K943812VIDAS LYME SCREEN IILSRSubstantially Equivalent
K942050HEMOLAB COFAC IXGJTSubstantially Equivalent
K942049BIOMERIEUX HEMOLAB COFAC IIGJTSubstantially Equivalent
K935851BIOMERIEUX HEMOLAB COFAC XGJTSubstantially Equivalent
K935850BIOMERIEUX HEMOLAB COFAC VIIGJTSubstantially Equivalent
K934210HEMOLAB PROTEIN C CHROMOGENIC ASSAYGGPSubstantially Equivalent
K934156BIOMERIEUX HEMOLAB AT IIIJBQSubstantially Equivalent
K931992HEMOLABGKPSubstantially Equivalent
K943811ENZYME-LINKED FLUORESCENT IMMUNOASSAYCFTSubstantially Equivalent
K933549VIDAS CMV IGM ASSAYLKQSubstantially Equivalent
K934274HEMOLAB HEPARICHROM ASSAYKFFSubstantially Equivalent
K925493BIOMERIEUX HEMOLAB THROMBICALCI-TESTGJASubstantially Equivalent
K935816VIDAS T UPTAKEKHQSubstantially Equivalent
K934764VIDAS T3 ASSAYCDPSubstantially Equivalent
K930267BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMALGGCSubstantially Equivalent
K921989FDP - SLIDEX DIRECTGHHSubstantially Equivalent
K933010BIOMERIEUX HEMOLAB COFAC VIIIGJTSubstantially Equivalent
K932250VIDAS DIGOXIN (DIG)KXTSubstantially Equivalent
K933258VIDAS THEOPHYLLINE(THEO)KLSSubstantially Equivalent
K923903VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSALJYSubstantially Equivalent
K931031VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENTJFTSubstantially Equivalent
K931334VIDAS TOXO COMPETITION (TXC) ASSAYLGDSubstantially Equivalent
K931224VIDAS TOTAL IGE (IGE) ASSAYDGPSubstantially Equivalent
K925494BIOMERIEUX HEMOLAB FIBRINOMATGISSubstantially Equivalent
K926393VIDAS THYROXINE (T4) ASSAY (T4)KLISubstantially Equivalent
K922737VIDAS TOXO IG6 ASSAY (TX6)LGDSubstantially Equivalent
K925916VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARDLQLSubstantially Equivalent
K925915VITEK RAPID CALL-GRAM NEGATIV IDENT CARDLQMSubstantially Equivalent
K923166VIDAS TOXOPLASMA GONDII IGM ASSSAYLGDSubstantially Equivalent
K925498VIDAS ESTRADIOL (E2) ASSAYCHPSubstantially Equivalent
K923579MINIVIDAS INSTRUMENTJJESubstantially Equivalent
K925492BIOMERIEUX HEMOLAB THROMBOMATGJSSubstantially Equivalent
K924218BAC-T-SCREENJXASubstantially Equivalent
K925177VIDAS FREE THYROXINE(FT4) ASSAYCECSubstantially Equivalent
K923122VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMLFYSubstantially Equivalent
K922768RAPID NFT, MODIFICATIONJSWSubstantially Equivalent
K923212SLIDEX STAPH-KITJWXSubstantially Equivalent
K920001HEMOLAB SILIMAT REAGENTGFISubstantially Equivalent
K921816VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAYJLWSubstantially Equivalent
K921746VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMCGJSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

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

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