Company ยท US
Johnson & Johnson Clinical Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 1998. Name variants (Inc, Corp, punctuation) are merged.
33510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 3 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 2 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 2 |
| DHA | System, Test, Human Chorionic Gonadotropin | 2 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 |
| CDN | Urease, Photometric, Urea Nitrogen | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 |
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | 1 |
| CEM | Electrode, Ion Specific, Potassium | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CHP | Radioimmunoassay, Estradiol | 1 |
| CJY | Azo Dye, Calcium | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 |
| JGP | Lowry (Colorimetric), Total Protein | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 25, 1998 | K980283 | VITROS CHEMISTRY PRODUCTS CRBM SLIDES Johnson & Johnson Clinical Diagnostics, Inc. | KLT |
| Jan 13, 1998 | K974644 | VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS Johnson & Johnson Clinical Diagnostics, Inc. | JJX |
| Sep 25, 1997 | K973517 | VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS Johnson & Johnson Clinical Diagnostics, Inc. | JJY |
| Sep 4, 1997 | K973030 | VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) Johnson & Johnson Clinical Diagnostics, Inc. | JJY |
| Jun 24, 1997 | K972133 | VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070) Johnson & Johnson Clinical Diagnostics, Inc. | JLS |
| Apr 14, 1997 | K970894 | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075) Johnson & Johnson Clinical Diagnostics, Inc. | DHA |
| Mar 18, 1997 | K970643 | VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) Johnson & Johnson Clinical Diagnostics, Inc. | CHP |
| Mar 18, 1997 | K965142 | VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15) Johnson & Johnson Clinical Diagnostics, Inc. | CEC |
| Feb 25, 1997 | K970281 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS Johnson & Johnson Clinical Diagnostics, Inc. | CFT |
| Feb 20, 1997 | K964982 | VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) Johnson & Johnson Clinical Diagnostics, Inc. | CEP |
| Feb 18, 1997 | K964960 | VITROS CHEMISTRY PRODUCTS UPRO SLIDES Johnson & Johnson Clinical Diagnostics, Inc. | JGP |
| Feb 4, 1997 | K964720 | VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) Johnson & Johnson Clinical Diagnostics, Inc. | CGJ |
| Jan 30, 1997 | K970016 | VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020) Johnson & Johnson Clinical Diagnostics, Inc. | CDP |
| Jan 27, 1997 | K965048 | VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015) Johnson & Johnson Clinical Diagnostics, Inc. | JJY |
| Dec 18, 1996 | K964721 | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005) Johnson & Johnson Clinical Diagnostics, Inc. | KLI |
| Dec 16, 1996 | K964558 | VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001) Johnson & Johnson Clinical Diagnostics, Inc. | JLW |
| Nov 27, 1996 | K964310 | VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) Johnson & Johnson Clinical Diagnostics, Inc. | CDP |
| Nov 27, 1996 | K964308 | VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025) Johnson & Johnson Clinical Diagnostics, Inc. | KHQ |
| Oct 18, 1996 | K962919 | VITROS IMMUNODIAGNOSTIC SYSTEM Johnson & Johnson Clinical Diagnostics, Inc. | KHO |
| Jun 26, 1996 | K962235 | VITROS SPECIALTY DILUENT Johnson & Johnson Clinical Diagnostics, Inc. | JJE |
| May 24, 1996 | K955904 | EKTACHEM DT LDL CHOLESTEROL KIT Johnson & Johnson Clinical Diagnostics, Inc. | MRR |
| May 17, 1996 | K955286 | EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU) Johnson & Johnson Clinical Diagnostics, Inc. | CGA |
| May 15, 1996 | K961196 | EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) Johnson & Johnson Clinical Diagnostics, Inc. | CDN |
| May 7, 1996 | K961226 | EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE Johnson & Johnson Clinical Diagnostics, Inc. | CJY |
| May 7, 1996 | K961115 | EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+) Johnson & Johnson Clinical Diagnostics, Inc. | CEM |
| May 7, 1996 | K961099 | EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+) Johnson & Johnson Clinical Diagnostics, Inc. | JGS |
| Dec 18, 1995 | K954933 | EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN Johnson & Johnson Clinical Diagnostics, Inc. | LDP |
| Jul 31, 1995 | K953197 | EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP) Johnson & Johnson Clinical Diagnostics, Inc. | DCK |
| Jul 26, 1995 | K952284 | AMERLITE TBG ASSAY Johnson & Johnson Clinical Diagnostics, Inc. | CEE |
| Jul 17, 1995 | K952283 | AMERLITE HCG-60 ASSAY Johnson & Johnson Clinical Diagnostics, Inc. | DHA |
| Jul 14, 1995 | K952211 | AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q) Johnson & Johnson Clinical Diagnostics, Inc. | JLW |
| Jul 3, 1995 | K952285 | AMERLITE FSH ASSAY Johnson & Johnson Clinical Diagnostics, Inc. | CGJ |
| Jun 20, 1995 | K952286 | AMERLITE FERRITIN II ASSAY Johnson & Johnson Clinical Diagnostics, Inc. | DBF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||