FDA 510(k) Applications Submitted by JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K970016 01/02/1997 VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K970281 01/24/1997 VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K970643 02/20/1997 VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K970894 03/11/1997 VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K972133 06/06/1997 VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K973030 08/14/1997 VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K973517 09/17/1997 VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K964308 10/29/1996 VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K964310 10/29/1996 VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K964558 11/13/1996 VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K964720 11/25/1996 VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K964721 11/25/1996 VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K964982 12/12/1996 VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K974644 12/12/1997 VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K965048 12/18/1996 VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K965142 12/23/1996 VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K962235 06/11/1996 VITROS SPECIALTY DILUENT JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K980283 01/26/1998 VITROS CHEMISTRY PRODUCTS CRBM SLIDES JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K961196 03/27/1996 EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K961226 03/29/1996 EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K961099 03/19/1996 EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K961115 03/20/1996 EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K962919 07/26/1996 VITROS IMMUNODIAGNOSTIC SYSTEM JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K955286 11/16/1995 EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K964960 12/11/1996 VITROS CHEMISTRY PRODUCTS UPRO SLIDES JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
K955904 12/29/1995 EKTACHEM DT LDL CHOLESTEROL KIT JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.


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