Medical Device Manufacturer · US , Mchenry , IL

Biokit USA, Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1984

16

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biokit USA, Inc. Microbiology ✕

9 devices

1-9 of 9

Cleared Jan 11, 1993

Microbiology · 525d

Cleared Oct 18, 1991

Microbiology · 256d

Cleared Jan 25, 1991

RHEUMAGEN ASO T-CONTROL

Microbiology · 128d

Cleared Nov 29, 1989

MODIFIED RUBAGEN

Microbiology · 20d

Cleared Oct 24, 1989

QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)

Microbiology · 98d

Cleared Aug 21, 1989

Microbiology · 94d

Cleared Apr 18, 1986

Microbiology · 127d

Cleared Oct 25, 1984

RPR TEST REDITEST

Microbiology · 30d

Cleared Jun 19, 1984

Microbiology · 12d