# Ortho Diagnostic Systems, Inc.

- Location (FDA's records): Carpinteria, CA
- FDA decisions: 126 (1981–1997): 126 510(k) clearances
- Product codes: GKZ (16), JJY (13), LFX (5), GJT (5), JPA (5), GGP (4), LJC (4), MCD (3), LGC (3), GQL (3), GJS (3), DAK (3)
- Predicates its devices cite: 8 (4 its own); citations of its devices by later devices: 8 (4 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 1 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Coulter Corp.: 1 (https://510kreport.com/company/coulter)
- Abx, Inc.: 1 (https://510kreport.com/company/abx)
- Coulter Electronics, Inc.: 1 (https://510kreport.com/company/coulter-electronics)

## Firms that cite its devices most
- Instrumentation Laboratory CO: 2 (https://510kreport.com/company/instrumentation-laboratory)
- Universal Reagents, Inc.: 1 (https://510kreport.com/company/universal-reagents)
- Bio-Rad: 1 (https://510kreport.com/company/bio-rad)

## Its most-cited devices
- K821975: Ortho*-BI-Level Assayed Whole Blood Tox (1982), cited by 1
- K951100: Ortho-Mune OK-Combo CD3-Fitc/CD19-PE (OKT3/OKB19A Monolclonal Antibody (Murine) (1996), cited by 1
- K883692: Ortho Factor Vii Deficient Plasma (1988), cited by 1
- K953981: Synthasil Aptt Reagent (1995), cited by 1
- K950482: Ortho-Mune OK-Comvo CD3-Fitc/CD8-PE (Okt 3/OKT8) Monoclonal Antibody (Murine) (1996), cited by 1
- K950568: Ortho-Mune OK-Combo CD3-Fitc/CD4-PE (OKT2/OKT4A) Monoclonal Antibody (Murine) (1996), cited by 1

## Recent decisions
- K951459: Ortho-Mune Okt 4A (CD4) - Monoclonal Antibody (Murine) Fitc Conjugate (Jul 14, 1997)
- K951632: Ortho-Mune OK-Combo Control IGG2A-Fitc/IGG2A-PE Monoclonal Antibody (Murine) (Mar 6, 1997)
- K964754: Ortho-Mune Okb (CD19)- Monoclonal Antibody (Murine) Phycoerythrine Conjugate (Jan 22, 1997)
- K963902: Quantitative Fibrinogen Assay (Nov 29, 1996)
- K951100: Ortho-Mune OK-Combo CD3-Fitc/CD19-PE (OKT3/OKB19A Monolclonal Antibody (Murine) (May 13, 1996)
- K950568: Ortho-Mune OK-Combo CD3-Fitc/CD4-PE (OKT2/OKT4A) Monoclonal Antibody (Murine) (May 13, 1996)
- K950625: Ortho-Mune OK-Combo CD40FITC/CD8-PE (OKT4A/OKT8) Monoclonal Antibody (Murine) (May 13, 1996)
- K950482: Ortho-Mune OK-Comvo CD3-Fitc/CD8-PE (Okt 3/OKT8) Monoclonal Antibody (Murine) (May 10, 1996)

Source page: https://510kreport.com/company/ortho-diagnostic-systems