FDA 510(k) Applications Submitted by CHERYL WINTERS-HEARD

FDA 510(k) Number Submission Date Device Name Applicant
K930267 01/19/1993 BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL BIOMERIEUX VITEK, INC.
K920661 02/13/1992 VIDAS CMV IGG ASSAY VITEK SYSTEMS, INC.
K921302 03/19/1992 VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM VITEK SYSTEMS, INC.
K931992 04/23/1993 HEMOLAB BIOMERIEUX VITEK, INC.
K942049 04/28/1994 BIOMERIEUX HEMOLAB COFAC II BIOMERIEUX VITEK, INC.
K942050 04/28/1994 HEMOLAB COFAC IX BIOMERIEUX VITEK, INC.
K952095 05/04/1995 VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) BIOMERIEUX VITEK, INC.
K912371 05/29/1991 BIOMERIEUX RSV DIRECT IF KIT VITEK SYSTEMS, INC.
K922737 06/08/1992 VIDAS TOXO IG6 ASSAY (TX6) BIOMERIEUX VITEK, INC.
K933010 06/21/1993 BIOMERIEUX HEMOLAB COFAC VIII BIOMERIEUX VITEK, INC.
K923903 08/04/1992 VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA BIOMERIEUX VITEK, INC.
K934156 08/27/1993 BIOMERIEUX HEMOLAB AT III BIOMERIEUX VITEK, INC.
K934210 08/30/1993 HEMOLAB PROTEIN C CHROMOGENIC ASSAY BIOMERIEUX VITEK, INC.
K934274 08/31/1993 HEMOLAB HEPARICHROM ASSAY BIOMERIEUX VITEK, INC.
K925492 11/02/1992 BIOMERIEUX HEMOLAB THROMBOMAT BIOMERIEUX VITEK, INC.
K925493 11/02/1992 BIOMERIEUX HEMOLAB THROMBICALCI-TEST BIOMERIEUX VITEK, INC.
K925494 11/02/1992 BIOMERIEUX HEMOLAB FIBRINOMAT BIOMERIEUX VITEK, INC.
K905211 11/20/1990 VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY VITEK SYSTEMS, INC.
K925915 11/23/1992 VITEK RAPID CALL-GRAM NEGATIV IDENT CARD BIOMERIEUX VITEK, INC.
K925916 11/23/1992 VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD BIOMERIEUX VITEK, INC.
K935850 12/08/1993 BIOMERIEUX HEMOLAB COFAC VII BIOMERIEUX VITEK, INC.
K935851 12/08/1993 BIOMERIEUX HEMOLAB COFAC X BIOMERIEUX VITEK, INC.
K915884 12/12/1991 VIDAS CHLAMYDIA ASSAY, MODIFICATION VITEK SYSTEMS, INC.
K960677 02/16/1996 KANGAROO JEJUNAL FEEDING SYSTEM SHERWOOD MEDICAL CO.


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