Medical Device Manufacturer · US , Boonton Twp , NJ

Euroimmun Us, LLC - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2006

Recent clearances: EUROIMMUN ANTI-CCP ELISA, EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT, EUROIMMUN ANA IFA: HEP-20-10

View 6 510(k) Devices ↓

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Euroimmun Us, LLC Immunology ✕

5 devices

1-5 of 5

Cleared Dec 31, 2007

EUROIMMUN ANTI-CCP ELISA

Immunology · 284d

Cleared May 22, 2007

EUROIMMUN ANA IFA: HEP-20-10

Immunology · 63d

Cleared Oct 05, 2006

EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT

Immunology · 136d

Cleared Sep 08, 2006

EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.

Immunology · 177d

Cleared Feb 16, 2006

EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM

Immunology · 255d