Medical Device Manufacturer · US , Scarborough , ME

Applications Lab - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1985

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Applications Lab Immunology ✕

10 devices

1-10 of 10

Cleared Mar 14, 1985

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M

Immunology · 29d

Cleared Mar 14, 1985

SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN

Immunology · 29d

Cleared Mar 05, 1985

SPQ TEST SYSTEM FOR HAPTOGLOBIN

Immunology · 20d

Cleared Mar 05, 1985

SPQ TEST SYSTEM FOR COMPLEMENT C3

Immunology · 20d

Cleared Mar 05, 1985

SPQ TEST SYSTEM FOR TRANSFERRIN

Immunology · 20d

Cleared Mar 05, 1985

SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN

Immunology · 18d

Cleared Mar 01, 1985

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A

Immunology · 16d

Cleared Mar 01, 1985

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G

Immunology · 16d

Cleared Mar 01, 1985

SPQ TEST SYSTEM FOR COMPLEMENT C4

Immunology · 16d

Cleared Mar 01, 1985

SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN

Immunology · 16d