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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