Medical Device Manufacturer · US , Mchenry , IL

Smithkline Diagnostics, Inc. - FDA 510(k) Cleared Devices

42 submissions · 42 cleared · Since 1976

42

Total

42

Cleared

0

Denied

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

5 devices

1-5 of 5

Cleared Nov 06, 1996

Hematology · 233d

Cleared May 23, 1988

HEMOCCULT SENSITIVE TEST

Hematology · 108d

Cleared Dec 09, 1986

HEMOCCULT WIPE TEST

Hematology · 133d

Cleared Oct 08, 1982

Hematology · 105d

Cleared Jun 22, 1982

SPINCHEM ACID PHOSPHATASE REAGENT

Hematology · 15d