Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Johnson & Johnson Clinical Diagnostics, Inc. — Predicate Candidate Screening
33 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
39 daysmedian FDA review time
84 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980283 | VITROS CHEMISTRY PRODUCTS CRBM SLIDES | Johnson & Johnson Clinical Diagnostics, Inc. | 1998-02-25 | 30 | 3 |
| K974644 | VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS | Johnson & Johnson Clinical Diagnostics, Inc. | 1998-01-13 | 32 | 0 |
| K973517 | VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-09-25 | 8 | 0 |
| K973030 | VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.130 | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-09-04 | 21 | 1 |
| K972133 | VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-06-24 | 18 | 0 |
| K970894 | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK ( | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-04-14 | 34 | 0 |
| K970643 | VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-03-18 | 26 | 0 |
| K965142 | VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM. | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-03-18 | 85 | 0 |
| K970281 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALI | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-25 | 32 | 0 |
| K964982 | VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-20 | 70 | 0 |
| K964960 | VITROS CHEMISTRY PRODUCTS UPRO SLIDES | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-18 | 69 | 0 |
| K964720 | VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 100 | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-04 | 71 | 0 |
| K970016 | VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM. | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-01-30 | 28 | 1 |
| K965048 | VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-01-27 | 40 | 0 |
| K964721 | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-12-18 | 23 | 1 |
| K964558 | VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 100 | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-12-16 | 33 | 0 |
| K964310 | VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GE | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-11-27 | 29 | 3 |
| K964308 | VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GE | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-11-27 | 29 | 0 |
| K962919 | VITROS IMMUNODIAGNOSTIC SYSTEM | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-10-18 | 84 | 3 |
| K962235 | VITROS SPECIALTY DILUENT | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-06-26 | 15 | 2 |
| K955904 | EKTACHEM DT LDL CHOLESTEROL KIT | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-05-24 | 147 | 0 |
| K955286 | EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-05-17 | 183 | 4 |
| K961196 | EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-05-15 | 49 | 1 |
| K961099 | EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-05-07 | 49 | 0 |
| K961226 | EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-05-07 | 39 | 1 |
| K961115 | EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-05-07 | 48 | 0 |
| K954933 | EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-12-18 | 52 | 1 |
| K953197 | EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP) | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-07-31 | 21 | 2 |
| K952284 | AMERLITE TBG ASSAY | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-07-26 | 71 | 0 |
| K952283 | AMERLITE HCG-60 ASSAY | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-07-17 | 62 | 0 |
| K952211 | AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q) | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-07-14 | 64 | 0 |
| K952285 | AMERLITE FSH ASSAY | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-07-03 | 48 | 0 |
| K952286 | AMERLITE FERRITIN II ASSAY | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-06-20 | 35 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda