Medical Device Manufacturer · US , Rochester , NY

Johnson & Johnson Clinical Diagnostics, Inc.

33 submissions · 33 cleared · Since 1995
33
Total
33
Cleared
0
Denied

Johnson & Johnson Clinical Diagnostics, Inc. — FDA 510(k) Submissions

Johnson & Johnson Clinical Diagnostics, Inc. has submitted 33 FDA 510(k) premarket notifications since 1995, of which 33 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Multi-analyte Controls, All Kinds (assayed), Radioimmunoassay, Thyroid-stimulating Hormone, System, Test, Human Chorionic Gonadotropin, Radioimmunoassay, Follicle-stimulating Hormone, Radioimmunoassay, Total Triiodothyronine . Use the specialty filter in the sidebar to narrow results.

33 devices
1–25 of 33
VITROS CHEMISTRY PRODUCTS CRBM SLIDES
K980283 · KLT Enzyme Immunoassay,... · Chemistry
Feb 1998 30d
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
K974644 · JJX Single (specified)... · Chemistry
Jan 1998 32d
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
K973517 · JJY Multi-analyte Controls,... · Chemistry
Sep 1997 8d
VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)
K973030 · JJY Multi-analyte Controls,... · Chemistry
Sep 1997 21d
VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)
K972133 · JLS Radioimmunoassay,... · Chemistry
Jun 1997 18d
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)
K970894 · DHA System, Test, Human... · Chemistry
Apr 1997 34d
VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)
K965142 · CEC Radioimmunoassay, Free... · Chemistry
Mar 1997 85d
VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)
K970643 · CHP Radioimmunoassay, Estradiol · Chemistry
Mar 1997 26d
VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS
K970281 · CFT Radioimmunoassay,... · Chemistry
Feb 1997 32d
VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)
K964982 · CEP Radioimmunoassay,... · Chemistry
Feb 1997 70d
VITROS CHEMISTRY PRODUCTS UPRO SLIDES
K964960 · JGP Lowry (colorimetric),... · Chemistry
Feb 1997 69d
VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)
K964720 · CGJ Radioimmunoassay,... · Chemistry
Feb 1997 71d
VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020)
K970016 · CDP Radioimmunoassay, Total... · Chemistry
Jan 1997 28d
VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015)
K965048 · JJY Multi-analyte Controls,... · Chemistry
Jan 1997 40d
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)
K964721 · KLI Enzyme Immunoassay,... · Chemistry
Dec 1996 23d
VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)
K964558 · JLW Radioimmunoassay,... · Chemistry
Dec 1996 33d
VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)
K964308 · KHQ Radioassay,... · Chemistry
Nov 1996 29d
VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)
K964310 · CDP Radioimmunoassay, Total... · Chemistry
Nov 1996 29d
VITROS IMMUNODIAGNOSTIC SYSTEM
K962919 · KHO Fluorometer, For Clinical... · Chemistry
Oct 1996 84d
VITROS SPECIALTY DILUENT
K962235 · JJE Analyzer, Chemistry... · Chemistry
Jun 1996 15d
EKTACHEM DT LDL CHOLESTEROL KIT
K955904 · MRR System, Test, Low... · Chemistry
May 1996 147d
EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)
K955286 · CGA Glucose Oxidase, Glucose · Chemistry
May 1996 183d
EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)
K961196 · CDN Urease, Photometric, Urea... · Chemistry
May 1996 49d
EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+)
K961099 · JGS Electrode, Ion Specific,... · Chemistry
May 1996 49d
EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+)
K961115 · CEM Electrode, Ion Specific,... · Chemistry
May 1996 48d
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