Medical Device Manufacturer · US , Portland , ME

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

3 submissions · 3 cleared · Since 1986

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Alerchek, Inc. Immunology ✕

3 devices

1-3 of 3

Cleared Mar 08, 1989

FLIPSCREEN (TM) TOTAL E IMMUNOASSAY

Immunology · 71d

Cleared Feb 17, 1988

Immunology · 86d

Cleared Apr 22, 1986

FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY

Immunology · 109d