Medical Device Manufacturer · US , Cambridge, , MA

Immunetics, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1999

Recent clearances: QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024, QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Immunetics, Inc. Microbiology ✕

4 devices

1-4 of 4

Cleared Jun 03, 2004

QUICKELISA ANTHRAX-PA KIT

Microbiology · 107d

Cleared May 10, 2001

IMMUNETICS C6 LYME ELISA KIT

Microbiology · 156d

Cleared Sep 21, 1999

QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024

Microbiology · 174d

Cleared Sep 21, 1999

QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024

Microbiology · 174d