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FDA 510(k) Applications Submitted by BIOMERIEUX VITEK, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K952095
05/04/1995
VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)
BIOMERIEUX VITEK, INC.
K962609
07/03/1996
GRAM NEGATIVE IDENTIFICATION PLUS CARD
BIOMERIEUX VITEK, INC.
K962549
06/28/1996
VIDAS CREATINE KINASE MB ASSAY 30-421
BIOMERIEUX VITEK, INC.
K972895
08/05/1997
VIDAS ROTAVIRUS (RTV) ASSAY
BIOMERIEUX VITEK, INC.
K973819
10/07/1997
VIDAS D-DIMER (DD) ASSAY
BIOMERIEUX VITEK, INC.
K964887
12/06/1996
VIDAS C. DIFFICILE TOXIN A II ASSAY
BIOMERIEUX VITEK, INC.
K955627
12/11/1995
VIDAS CHLAMYDIA BLOCKING ASSAY
BIOMERIEUX VITEK, INC.
K955647
12/12/1995
VIDAS ESTRADIOL II (E2II) ASSAY
BIOMERIEUX VITEK, INC.
K965092
12/19/1996
VIDAS ROTAVIRUS ASSAY
BIOMERIEUX VITEK, INC.
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