Medical Device Manufacturer · US , Los Angeles , CA

Grifols USA, LLC - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2012

Recent clearances: GLIADIN IGA AND GLIADIN LGA, INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Grifols USA, LLC Immunology ✕

2 devices

1-2 of 2

Cleared Dec 14, 2012

GLIADIN IGA AND GLIADIN LGA

Immunology · 394d

Cleared Aug 24, 2012

INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT

Immunology · 218d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 16, 2026