Medical Device Manufacturer · US , Mchenry , IL

Diagnostic Technology, Inc. - FDA 510(k) Cleared Devices

28 submissions · 28 cleared · Since 1979

28

Total

28

Cleared

0

Denied

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

11 devices

1-11 of 11

Cleared May 07, 1986

PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS

Hematology · 77d

Cleared Apr 04, 1986

PICOSCALE BLOOD CELL COUNTER, MODEL PS-5

Hematology · 77d

Cleared Nov 05, 1985

PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1

Hematology · 110d

Cleared Nov 30, 1984

COUNT-A-PART PLUS

Hematology · 213d

Cleared Aug 16, 1984

PICOSCAL BLOOD CELL COUNTER PS-4

Hematology · 78d

Cleared Feb 10, 1984

PHA-1 PROGRAMMABLE HEMATOLOGY ANALYZ

Hematology · 71d

Cleared Feb 04, 1982

Hematology · 28d

Cleared Jul 01, 1981

Hematology · 75d

Cleared Oct 11, 1979

COUNTER-CHECK PLUS

Hematology · 36d

Cleared Oct 11, 1979

COUNTER-CHECK PLUS NORMAL, HIGH ABN.

Hematology · 34d

Cleared Jan 17, 1979

COUNTER CHECK, H001, H002, H003

Hematology · 14d