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. Hematology ✕

3 devices

1-3 of 3

Cleared Oct 23, 2008

BINAXNOW G6PD TEST

Hematology · 295d

Cleared Oct 31, 1991

BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT

Hematology · 132d

Cleared Aug 12, 1988

BINAX EQUATE GLYCOHEMOGLOBIN

Hematology · 268d