Medical Device Manufacturer · US , Mchenry , IL

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

16 submissions · 16 cleared · Since 1984

Total

Cleared

Denied

Biokit USA, Inc. has 16 FDA 510(k) cleared medical devices. Based in Mchenry, US.

Historical record: 16 cleared submissions from 1984 to 1993. Primary specialty: Microbiology.

Browse the FDA 510(k) cleared devices submitted by Biokit USA, Inc. Filter by specialty or product code using the sidebar.

Biokit USA, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

16 devices

1-12 of 16

RHEUMAGEN RF T-CONTROL

RHEUMAGEN ASO T-CONTROL

K904311 · GTQ

Microbiology · 128d

Cleared Oct 01, 1990

RHEUMAGEN CRP T-CONTROL

QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)

K896271 · DHR

Immunology · 9d

Cleared Nov 08, 1989

QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL

K896272 · DCN

Immunology · 9d

Cleared Oct 24, 1989

QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)

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

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

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