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Johnson & Johnson Clinical Diagnostics, Inc.

33 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
VITROS CHEMISTRY PRODUCTS CRBM SLIDES (K980283)Johnson & Johnson Clinical Diagnostics, Inc.1998-02-25
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS (K974644)Johnson & Johnson Clinical Diagnostics, Inc.1998-01-13
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS (K973517)Johnson & Johnson Clinical Diagnostics, Inc.1997-09-25
VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) (K973030)Johnson & Johnson Clinical Diagnostics, Inc.1997-09-04
VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070) (K972133)Johnson & Johnson Clinical Diagnostics, Inc.1997-06-24
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075) (K970894)Johnson & Johnson Clinical Diagnostics, Inc.1997-04-14
VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) (K970643)Johnson & Johnson Clinical Diagnostics, Inc.1997-03-18
VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15) (K965142)Johnson & Johnson Clinical Diagnostics, Inc.1997-03-18
VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS (K970281)Johnson & Johnson Clinical Diagnostics, Inc.1997-02-25
VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) (K964982)Johnson & Johnson Clinical Diagnostics, Inc.1997-02-20
VITROS CHEMISTRY PRODUCTS UPRO SLIDES (K964960)Johnson & Johnson Clinical Diagnostics, Inc.1997-02-18
VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) (K964720)Johnson & Johnson Clinical Diagnostics, Inc.1997-02-04
VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020) (K970016)Johnson & Johnson Clinical Diagnostics, Inc.1997-01-30
VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015) (K965048)Johnson & Johnson Clinical Diagnostics, Inc.1997-01-27
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005) (K964721)Johnson & Johnson Clinical Diagnostics, Inc.1996-12-18
VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001) (K964558)Johnson & Johnson Clinical Diagnostics, Inc.1996-12-16
VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) (K964310)Johnson & Johnson Clinical Diagnostics, Inc.1996-11-27
VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025) (K964308)Johnson & Johnson Clinical Diagnostics, Inc.1996-11-27
VITROS IMMUNODIAGNOSTIC SYSTEM (K962919)Johnson & Johnson Clinical Diagnostics, Inc.1996-10-18
VITROS SPECIALTY DILUENT (K962235)Johnson & Johnson Clinical Diagnostics, Inc.1996-06-26
EKTACHEM DT LDL CHOLESTEROL KIT (K955904)Johnson & Johnson Clinical Diagnostics, Inc.1996-05-24
EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU) (K955286)Johnson & Johnson Clinical Diagnostics, Inc.1996-05-17
EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) (K961196)Johnson & Johnson Clinical Diagnostics, Inc.1996-05-15
EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+) (K961099)Johnson & Johnson Clinical Diagnostics, Inc.1996-05-07
EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE (K961226)Johnson & Johnson Clinical Diagnostics, Inc.1996-05-07
EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+) (K961115)Johnson & Johnson Clinical Diagnostics, Inc.1996-05-07
EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN (K954933)Johnson & Johnson Clinical Diagnostics, Inc.1995-12-18
EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP) (K953197)Johnson & Johnson Clinical Diagnostics, Inc.1995-07-31
AMERLITE TBG ASSAY (K952284)Johnson & Johnson Clinical Diagnostics, Inc.1995-07-26
AMERLITE HCG-60 ASSAY (K952283)Johnson & Johnson Clinical Diagnostics, Inc.1995-07-17
AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q) (K952211)Johnson & Johnson Clinical Diagnostics, Inc.1995-07-14
AMERLITE FSH ASSAY (K952285)Johnson & Johnson Clinical Diagnostics, Inc.1995-07-03
AMERLITE FERRITIN II ASSAY (K952286)Johnson & Johnson Clinical Diagnostics, Inc.1995-06-20

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