Medical Device Manufacturer · US , Walker , MI

Allergenetics - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1982

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Allergenetics Immunology ✕

5 devices

1-5 of 5

Cleared May 28, 1985

ALLERGENETICS IGE FAST TEST

Immunology · 43d

Cleared Mar 12, 1984

Immunology · 161d

Cleared Feb 10, 1984

TOTAL IGE FAST TEST

Immunology · 43d

Cleared Feb 03, 1984

LABELED 125I ANTI-IGE

Immunology · 123d

Cleared Nov 10, 1982

ALLERGENETICS IGE-FAST TEST

Immunology · 98d