Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Hyphen Biomed

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K071255 ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040ALCO2007-09-07 View
510(k) K050367 BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6KFF2006-05-24 View
510(k) K050365 BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202GGP2005-12-27 View
510(k) K051472 BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATORGGN2005-12-23 View
510(k) K043007 BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105JBQ2005-11-07 View
510(k) K043451 BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATORGGN2005-03-17 View
↑