Medical Device Manufacturer · US , Greenwich , CT

American Diagnostica, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1994

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - American Diagnostica, Inc. Hematology ✕

10 devices

1-10 of 10

Cleared Feb 13, 2008

Hematology · 34d

Cleared Aug 15, 2007

SPECTROLYSE PAI-1, MODEL 101201

Hematology · 285d

Cleared Oct 17, 2005

ACTICLOT, MODEL 824

Hematology · 73d

Cleared Apr 16, 2002

ACTICHROME HEPARIN (ANTI-FIIA)

Hematology · 162d

Cleared Mar 13, 2002

IMUBIND TPA ELISA, MODEL 860

Hematology · 142d

Cleared Mar 08, 2002

ACTICHROME HEPARIN (ANTI-FXA), MODEL 832

Hematology · 154d

Cleared Mar 07, 2002

IMUBIND PLASMA PAI-1 ELISA,MODEL 822

Hematology · 167d

Cleared Sep 14, 2001

ACTICLOT PROTEIN S, MODEL 843L

Hematology · 49d

Cleared Apr 05, 1995

DV TEST AND DVV CONFIRM

Hematology · 426d

Cleared Sep 19, 1994

DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA

Hematology · 322d