Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Johnson & Johnson. FDA records under its name, each linked to the record. See the Johnson & Johnson group view.
As of Nov 15, 2026, FDA's public records list Johnson & Johnson Clinical Diagnostics with 33 510(k) clearances. The most recent is a 510(k) clearance dated Feb 25, 1998: VITROS CHEMISTRY PRODUCTS CRBM SLIDES.
| Feb 25, 1998 | VITROS CHEMISTRY PRODUCTS CRBM SLIDESK980283 · KLT | 510(k) clearances |
| Jan 13, 1998 | VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSK974644 · JJX | 510(k) clearances |
| Sep 25, 1997 | VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSK973517 · JJY | 510(k) clearances |
| Sep 4, 1997 | VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)K973030 · JJY | 510(k) clearances |
| Jun 24, 1997 | VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)K972133 · JLS | 510(k) clearances |
| Apr 14, 1997 | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)K970894 · DHA | 510(k) clearances |
| Mar 18, 1997 | VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)K970643 · CHP | 510(k) clearances |
| Mar 18, 1997 | VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)K965142 · CEC | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
