510(k) Report

FDA applicant

Hyphen Biomed

Mason, OH6 decisions2005–200713 recalls

FDA records 6 decisions for Hyphen Biomed (Mason, OH) from 2005 to 2007: 6 510(k) clearances. Most are in product codes GGN (Plasma, Coagulation Control) and JBQ (Antithrombin Iii Quantitation). Its devices cite 10 predicates, 0 of them its own earlier devices. 13 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Hyphen Biomed’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2026

2011: 22018: 32019: 52022: 12023: 12026 (partial year): 1
2007high 5 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Hyphen Biomed by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hyphen Biomed’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GGNPlasma, Coagulation Control2decisions
  • JBQAntithrombin Iii Quantitation1decision
  • LCOPlatelet Factor 4 Radioimmunoassay1decision
  • GGPTest, Qualitative And Quantitative Factor Deficiency1decision
  • KFFAssay, Heparin1decision

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K071255Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040AHyphen Biomed · 20071cites it

What has FDA decided for it lately?

  • K071255Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040AHyphen Biomed · 20078 recalls
  • K050367Biophen Heparin 3, Biophen Heparin 6Hyphen Biomed · 2006
  • K050365Biophen Protein C5, C2.5, Models 221205, 221202Hyphen Biomed · 20051 recall
  • K051472Biophen LMWH Control, LMWH Control Low, Ufh Control, Heparin Calibrator & Ufh CalibratorHyphen Biomed · 20054 recalls
  • K043007Biophen Antithrombin 2.5, Reference # 221102; Biophen Antithrombin 5, Reference # 221105Hyphen Biomed · 2005
  • K043451Biophen Normal and Abnormal Control Plasma; Biophen Plasma CalibratorHyphen Biomed · 2005

All 6 as Hyphen Biomed →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K071255ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040AApr 1, 2026Class II
  • K050365BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity…Feb 1, 2023Class II
  • K051472BIOPHEN UFH Control PlasmaJun 28, 2022Class III
  • K071255ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.Jul 19, 2019Class II
  • K071255ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.Jul 19, 2019Class II
  • K051472BIOPHEN UFH Control C1, REF 224101Mar 19, 2019Class III