Medical Device Manufacturer · US , Little Falls , NJ

Photec Diagnostics, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1985

12

Total

12

Cleared

0

Denied

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

4 devices

1-4 of 4

Cleared Jan 24, 1986

APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1

Immunology · 51d

Cleared Aug 28, 1985

APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1

Immunology · 40d

Cleared Aug 22, 1985

APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN

Immunology · 23d

Cleared Jun 05, 1985

APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1

Immunology · 44d