bioMerieux, Inc. - FDA 510(k) Cleared Devices
251
Total
250
Cleared
1
Denied
251 devices
Cleared
Mar 02, 2010
CHROMID VRE AGAR, MODEL: REF 43 851
Microbiology
326d
Cleared
Nov 09, 2009
DENSICHECK PLUS
Microbiology
26d
Cleared
Sep 11, 2009
DENSICHEK PLUS
Microbiology
287d
Cleared
Aug 14, 2009
VITEK 2 GRAM NEGATIVE MEROPENEM
Microbiology
50d
Cleared
Jul 17, 2009
CHROMID MRSA AGAR, MODEL: REF 43 841
Microbiology
98d
Cleared
Jun 22, 2009
VIDAS CA 15-3 ASSAY
Immunology
487d
Cleared
Jun 18, 2009
VITEK 2 GRAM POSITIVE DAPTOMYCIN
Microbiology
59d
Cleared
Apr 10, 2009
VIDAS CA 125 II ASSAY
Immunology
407d
Cleared
Mar 16, 2009
VITEK 2 GRAM NEGATIVE DORIPENEM
Microbiology
213d
Cleared
Feb 18, 2009
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
Microbiology
93d
Cleared
Dec 23, 2008
VIDAS RUB IGG
Microbiology
280d
Cleared
Oct 09, 2008
VIDAS CEA (S) ASSAY
Immunology
258d
Cleared
Sep 26, 2008
VIDAS AFP ASSAY
Immunology
267d
Cleared
Jun 23, 2008
NUCLISENS EASYQ ENTEROVIRUS SYSTEM
Microbiology
602d
Cleared
Jun 11, 2008
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
Microbiology
70d
Cleared
Apr 30, 2008
VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE
Microbiology
93d
Cleared
Feb 29, 2008
VIDAS NT-PROBNP ASSAY, MODEL: 30 449
Chemistry
120d
Cleared
Feb 28, 2008
VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM
Microbiology
44d
Cleared
Jan 23, 2008
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
Microbiology
50d
Cleared
Dec 21, 2007
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
Microbiology
141d
Cleared
Dec 14, 2007
VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448
Chemistry
414d
Cleared
Dec 10, 2007
VITEK 2 GRAM NEGATIVE PIPERACILLIN
Microbiology
39d
Cleared
Nov 16, 2007
VITEK 2 GRAM POSITIVE TIGECYCLINE
Microbiology
53d
Cleared
Oct 15, 2007
VITEK 2 GRAM POSITIVE VANCOMYCIN
Microbiology
24d
Cleared
Oct 11, 2007
VIDAS B.R.A.H.M.S. PCT ASSAY
Microbiology
170d
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