# Hyphen Biomed

- Location (FDA's records): Mason, OH
- FDA decisions: 6 (2005–2007): 6 510(k) clearances
- Product codes: GGN (2), JBQ (1), LCO (1), GGP (1), KFF (1)
- Predicates its devices cite: 10 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Instrumentation Laboratory CO: 2 (https://510kreport.com/company/instrumentation-laboratory)
- Dade Behring, Inc.: 2 (https://510kreport.com/company/dade-behring)
- Kabi Pharmacia, Inc.: 1 (https://510kreport.com/company/kabi-pharmacia)
- Diagnostica Stago, Inc.: 1 (https://510kreport.com/company/diagnostica-stago)
- Genetic Testing Institute: 1 (https://510kreport.com/company/genetic-testing-institute)
- Chromogenix AB: 1 (https://510kreport.com/company/chromogenix)
- American Bioproducts Co.: 1 (https://510kreport.com/company/american-bioproducts)
- Bio-Rad: 1 (https://510kreport.com/company/bio-rad)

## Firms that cite its devices most
- Instrumentation Laboratory CO: 1 (https://510kreport.com/company/instrumentation-laboratory)

## Its most-cited devices
- K071255: Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040A (2007), cited by 1

## Recent decisions
- K071255: Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040A (Sep 7, 2007)
- K050367: Biophen Heparin 3, Biophen Heparin 6 (May 24, 2006)
- K050365: Biophen Protein C5, C2.5, Models 221205, 221202 (Dec 27, 2005)
- K051472: Biophen LMWH Control, LMWH Control Low, Ufh Control, Heparin Calibrator & Ufh Calibrator (Dec 23, 2005)
- K043007: Biophen Antithrombin 2.5, Reference # 221102; Biophen Antithrombin 5, Reference # 221105 (Nov 7, 2005)
- K043451: Biophen Normal and Abnormal Control Plasma; Biophen Plasma Calibrator (Mar 17, 2005)

Source page: https://510kreport.com/company/hyphen-biomed