Medical Device Manufacturer · US , Denver , CO

Biostar Medical Products, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1985

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biostar Medical Products, Inc. Immunology ✕

5 devices

1-5 of 5

Cleared Jul 14, 1989

QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA

Immunology · 45d

Cleared Jun 23, 1989

SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM

Immunology · 24d

Cleared Oct 08, 1986

READS RF TEST KIT FOR IGM RHEUMATOID FACTOR

Immunology · 48d

Cleared Jun 20, 1986

BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT

Immunology · 58d

Cleared Dec 16, 1985

BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT

Immunology · 103d