Medical Device Manufacturer · GB , Penicuik, Midlothian

Hycor Biomedical , Ltd. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2003

Recent clearances: AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA, AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA, AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hycor Biomedical , Ltd. Immunology ✕

4 devices

1-4 of 4

Cleared Mar 07, 2005

AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA

Immunology · 84d

Cleared Jan 20, 2004

AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA

Immunology · 50d

Cleared May 01, 2003

AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA

Immunology · 52d

Cleared Mar 21, 2003

AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA

Immunology · 43d