Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY, US
Johnson & Johnson Clinical Diagnostics, Inc. appears in FDA device records in Rochester, NY. FDA records list 33 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 33
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 33 510(k) clearances for Johnson & Johnson Clinical Diagnostics, Inc. between 1995 and 1998. The busiest year on record is 1996, with 12. The most recent is 1998, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 7 |
| 1996 | 12 |
| 1997 | 12 |
| 1998 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K980283 | VITROS CHEMISTRY PRODUCTS CRBM SLIDES | KLT | Substantially Equivalent | |
| K974644 | VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS | JJX | Substantially Equivalent | |
| K973517 | VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS | JJY | Substantially Equivalent | |
| K973030 | VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) | JJY | Substantially Equivalent | |
| K972133 | VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070) | JLS | Substantially Equivalent | |
| K970894 | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075) | DHA | Substantially Equivalent | |
| K970643 | VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) | CHP | Substantially Equivalent | |
| K965142 | VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15) | CEC | Substantially Equivalent | |
| K970281 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS | CFT | Substantially Equivalent | |
| K964982 | VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) | CEP | Substantially Equivalent | |
| K964960 | VITROS CHEMISTRY PRODUCTS UPRO SLIDES | JGP | Substantially Equivalent | |
| K964720 | VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) | CGJ | Substantially Equivalent | |
| K970016 | VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020) | CDP | Substantially Equivalent | |
| K965048 | VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015) | JJY | Substantially Equivalent | |
| K964721 | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005) | KLI | Substantially Equivalent | |
| K964558 | VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001) | JLW | Substantially Equivalent | |
| K964310 | VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) | CDP | Substantially Equivalent | |
| K964308 | VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025) | KHQ | Substantially Equivalent | |
| K962919 | VITROS IMMUNODIAGNOSTIC SYSTEM | KHO | Substantially Equivalent | |
| K962235 | VITROS SPECIALTY DILUENT | JJE | Substantially Equivalent | |
| K955904 | EKTACHEM DT LDL CHOLESTEROL KIT | MRR | Substantially Equivalent | |
| K955286 | EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU) | CGA | Substantially Equivalent | |
| K961196 | EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) | CDN | Substantially Equivalent | |
| K961226 | EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE | CJY | Substantially Equivalent | |
| K961115 | EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+) | CEM | Substantially Equivalent | |
| K961099 | EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+) | JGS | Substantially Equivalent | |
| K954933 | EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN | LDP | Substantially Equivalent | |
| K953197 | EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP) | DCK | Substantially Equivalent | |
| K952284 | AMERLITE TBG ASSAY | CEE | Substantially Equivalent | |
| K952283 | AMERLITE HCG-60 ASSAY | DHA | Substantially Equivalent | |
| K952211 | AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q) | JLW | Substantially Equivalent | |
| K952285 | AMERLITE FSH ASSAY | CGJ | Substantially Equivalent | |
| K952286 | AMERLITE FERRITIN II ASSAY | DBF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- CJYAzo Dye, Calcium
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- LDPColorimetry, Acetaminophen
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- KLTEnzyme Immunoassay, Carbamazepine
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DBFFerritin, Antigen, Antiserum, Control
- KHOFluorometer, For Clinical Use
- CGAGlucose Oxidase, Glucose
- JGPLowry (Colorimetric), Total Protein
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- KHQRadioassay, Triiodothyronine Uptake
- CHPRadioimmunoassay, Estradiol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- CEPRadioimmunoassay, Luteinizing Hormone
- JLSRadioimmunoassay, Progesterone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CEERadioimmunoassay, Thyroxine-Binding Globulin
- CDPRadioimmunoassay, Total Triiodothyronine
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- DHASystem, Test, Human Chorionic Gonadotropin
- MRRSystem, Test, Low Density, Lipoprotein
- CDNUrease, Photometric, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain