# Johnson & Johnson Clinical Diagnostics, Inc.

- Location (FDA's records): Rochester, NY
- FDA decisions: 33 (1995–1998): 33 510(k) clearances
- Product codes: JJY (3), DHA (2), CGJ (2), CDP (2), JLW (2), KHO (1), CEE (1), JJX (1), CDN (1), CEP (1), KHQ (1), CJY (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 20 (0 its own)
- Recalls linked to its devices: 37 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Ortho-Clinical Diagnostics, Inc.: 19 (https://510kreport.com/company/ortho-clinical-diagnostics)
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)

## Its most-cited devices
- K973517: Vitros Immunodiagnostic Products Range Verifiers (1997), cited by 8
- K953197: Ektachem Clinical Chemistry Slide C-Reactive Protein (CRP) (1995), cited by 2
- K962919: Vitros Immunodiagnostic System (1996), cited by 1
- K964558: Vitros Immunodiagnostics Products/TSH Reagent Pack (Gem. 1001)/TSH Calibrators (Gem.C001) (1996), cited by 1
- K970894: Vitros Immunodiagnostics Products Total B-HCG Reagent Pack (Gem.1075), Total B-HCG Calibrators (Gem.C075) (1997), cited by 1
- K961226: Ektachem Clinical Chemistry Calcium (CA) Slide (1996), cited by 1

## Recent decisions
- K980283: Vitros Chemistry Products CRBM Slides (Feb 25, 1998)
- K974644: Vitros Immunodiagnostic Products Range Verifiers (Jan 13, 1998)
- K973517: Vitros Immunodiagnostic Products Range Verifiers (Sep 25, 1997)
- K973030: Vitros Immunodiagnostics Products/CK-MB Reagent Pack (Gem.1300)/CK-MB Calibrators (Gem.C300) (Sep 4, 1997)
- K972133: Vitros Immunodiagnostics Products Progesterone Reagent Pack (Gem.1070), Progesterone Calibrators (Gem.C070) (Jun 24, 1997)
- K970894: Vitros Immunodiagnostics Products Total B-HCG Reagent Pack (Gem.1075), Total B-HCG Calibrators (Gem.C075) (Apr 14, 1997)
- K970643: Vitros Immunodiagnostics Products Estradiol Reagent Pack (Gem. 1050)/Estradiol Calibrators (Gem.C050) (Mar 18, 1997)
- K965142: Vitros Immunodiagnostics Products Free T4 Reagent Pack (Gem.1015) Free T4 Calibrators (Gem.CO15) (Mar 18, 1997)

Source page: https://510kreport.com/company/johnson-johnson-clinical-diagnostics