Medical Device Manufacturer · US , Mchenry , IL

Diatech, Inc. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 1984

17

Total

17

Cleared

0

Denied

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

17 devices

1-12 of 17

Cleared Aug 09, 1988

FIBRINOGENTEST-O

Hematology · 112d

Cleared Mar 12, 1986

COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.

Hematology · 92d

Cleared Jan 06, 1986

DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT

Hematology · 91d

Cleared Jan 06, 1986

DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT

Hematology · 91d

Cleared Sep 11, 1984

DIA T1, T2 & T3

Hematology · 90d

Cleared Jun 01, 1984

Hematology · 60d

Cleared Jun 01, 1984

Hematology · 60d

Cleared Jun 01, 1984

HEPARIN COAGULATION CONTROL PLASMA 1-

Hematology · 53d

Cleared Jun 01, 1984

OWREN'S VERONAL BUFFERR

Hematology · 50d

Cleared May 02, 1984

COAGULATION CONTROL PLASMA LEVEL 1/2/3

Hematology · 23d

Cleared May 01, 1984

DIA THROMBIN DIA PLASTIN

Hematology · 68d

Cleared Apr 30, 1984

FACTOR DEFICIENT SUBSTRATE PLASMA II

Hematology · 59d