Medical Device Manufacturer · US , Morton Grove , IL

Haemoscope Corp. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 1989

Recent clearances: THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY, THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES, THROMBELASTOGRAPH COAGULATION ANALYZER 3000S

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Haemoscope Corp. Hematology ✕

7 devices

1-7 of 7

Cleared Jan 31, 2007

RAPIDTEG TEG-ACT TEST

Hematology · 152d

Cleared Sep 01, 2004

THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY

Hematology · 86d

Cleared Sep 14, 2000

THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES

Hematology · 57d

Cleared May 05, 2000

THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES

Hematology · 186d

Cleared Jan 30, 1996

THROMBELASTOGRAPH COAGULATION ANALYZER 3000S

Hematology · 130d

Cleared Nov 01, 1990

THROMBELASTOGRAPH

Hematology · 50d

Cleared Oct 24, 1989

THROMBELASTOGRAPH(R)

Hematology · 21d