Medical Device Manufacturer · US , Mason , OH

Hyphen Biomed - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2005

Recent clearances: BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6, BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202, BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hyphen Biomed Hematology ✕

6 devices

1-6 of 6

Cleared Sep 07, 2007

ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A

Hematology · 126d

Cleared May 24, 2006

BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6

Hematology · 464d

Cleared Dec 27, 2005

BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202

Hematology · 316d

Cleared Dec 23, 2005

BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH...

Hematology · 203d

Cleared Nov 07, 2005

BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102

Hematology · 371d

Cleared Mar 17, 2005

BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA

Hematology · 93d