Medical Device Manufacturer · US , Conroe , TX

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

2 submissions · 2 cleared · Since 1987

2

Total

2

Cleared

0

Denied

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

2 devices

1-2 of 2

Cleared Sep 07, 1988

ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST

Immunology · 51d

Cleared Nov 04, 1987

AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT

Immunology · 91d