Medical Device Manufacturer · US , Mason , OH

Hyphen Biomed - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2005

Recent clearances: ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A, BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6, BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202

View 6 510(k) Devices ↓

6

Total

6

Cleared

0

Denied

Hyphen Biomed has 6 FDA 510(k) cleared medical devices. Based in Mason, US.

Historical record: 6 cleared submissions from 2005 to 2007. Primary specialty: Hematology.

Browse the FDA 510(k) cleared devices submitted by Hyphen Biomed Filter by specialty or product code using the sidebar.

Hyphen Biomed is one of 25955 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Hyphen Biomed

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