Medical Device Manufacturer · US , Carlsbad , CA

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

15 submissions · 15 cleared · Since 2000

15

Total

15

Cleared

0

Denied

FDA 510(k) cleared devices by Qualigen, Inc. Immunology ✕

4 devices

1-4 of 4

Cleared Apr 02, 2007

FASTPACK TOTAL PSA METHOD VERIFICATION KIT

Immunology · 185d

Cleared Nov 30, 2000

FASTPACK CALIBRATORS

Immunology · 58d

Cleared Nov 29, 2000

FASTPACK CONTROL

Immunology · 57d

Cleared Oct 25, 2000

FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER

Immunology · 22d