Medical Device Manufacturer · US , S. Portland , ME

Binax, Inc. - FDA 510(k) Cleared Devices

30 submissions · 30 cleared · Since 1986

30

Total

30

Cleared

0

Denied

FDA 510(k) Regulatory Record - Binax, Inc. Chemistry ✕

5 devices

1-5 of 5

Cleared Oct 06, 1988

BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY

Chemistry · 63d

Cleared Oct 06, 1988

BINAS LUTEINIZING HORMONE IRMA TEST KIT

Chemistry · 63d

Cleared Mar 01, 1988

BINAX PROLACTIN IRMA DIAGNOSTIC KIT

Chemistry · 41d

Cleared Oct 02, 1987

BINAX L.S. TSH IRMA TEST KIT

Chemistry · 45d

Cleared Aug 05, 1987

BINAX IRMA TOTAL BETA-HCG TEST KIT

Chemistry · 28d