# Organon Teknika Corp.

- Location (FDA's records): Durham, NC
- FDA decisions: 134 (1979–2000): 130 510(k) clearances and 4 original PMA approvals
- Product codes: MDB (19), FKT (9), JTN (8), FJI (7), KOC (5), DAP (5), GJS (5), JPA (5), LIB (4), JTC (3), GKP (3), KOI (3)
- Predicates its devices cite: 9 (4 its own); citations of its devices by later devices: 27 (4 its own)
- Recalls linked to its devices: 15 (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: 2 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- American Bioproducts Co.: 1 (https://510kreport.com/company/american-bioproducts)
- General Diagnostics: 1 (https://510kreport.com/company/general-diagnostics)
- Agen Biomedical, Ltd.: 1 (https://510kreport.com/company/agen-biomedical)

## Firms that cite its devices most
- bioMerieux, Inc.: 10 (https://510kreport.com/company/biomerieux)
- Renal Solutions, Inc.: 4 (https://510kreport.com/company/renal-solutions)
- B.Braun Medical, Inc.: 2 (https://510kreport.com/company/b-braun-medical)
- Wada, Inc.: 2 (https://510kreport.com/company/wada)
- Hdc Corp.: 1 (https://510kreport.com/company/hdc)
- Draeger Medical Systems, Inc.: 1 (https://510kreport.com/company/draeger-medical-systems)
- MIPM Mammendorfer Institut für Physik und Medizin GmbH: 1 (https://510kreport.com/company/mipm-mammendorfer-institut-fur-physik-und-medizin)
- Blink Device Company: 1 (https://510kreport.com/company/blink-device)

## Its most-cited devices
- K924453: Multi-Channel Discrete Analyzer (Mda-180) (1992), cited by 3
- K903505: Bact/Alert (TM) (1991), cited by 2
- K972698: Tof-Watch (1997), cited by 2
- K962857: Coag-a-Mate MTX (1997), cited by 2
- K992598: Tof-Watch SX (1999), cited by 2
- K993421: Bact/Alert SN (1999), cited by 1

## Recent decisions
- K003104: Bact/Alert CSR (Oct 20, 2000)
- K000492: Mda D-Dimer (Jun 7, 2000)
- K000378: Bact/Alert MB Culture Bottle (Mar 2, 2000)
- K994343: Bact/Alert SV (Feb 10, 2000)
- K993423: Bact/Alert SA (Dec 15, 1999)
- K993421: Bact/Alert SN (Dec 14, 1999)
- K993576: Bact/Alert MP Process Bottle (Dec 14, 1999)
- K992432: Bact/Alert FN (Sep 24, 1999)

Source page: https://510kreport.com/company/organon-teknika