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. Microbiology ✕

3 devices

1-3 of 3

Cleared Jun 07, 1996

FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT...

Microbiology · 143d

Cleared May 18, 1994

Microbiology · 218d

Cleared Jul 24, 1985

RAPID DIRECT STREP A LATEX AGGLUTINATION TEST

Microbiology · 19d