Medical Device Manufacturer · US , Cambridge , MA

Intracel Corp. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1995

Recent clearances: BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST, PRIMA SYSTEM - OLD, BARTELS ELISA - NEW, BARTELS CINAKIT CMV ANTIGENEMIA

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Intracel Corp. Microbiology ✕

4 devices

1-4 of 4

Cleared Nov 07, 2000

BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT

Microbiology · 25d

Cleared Dec 21, 1999

BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST

Microbiology · 265d

Cleared Mar 31, 1999

PRIMA SYSTEM - OLD, BARTELS ELISA - NEW

Microbiology · 30d

Cleared Dec 14, 1998

BARTELS CINAKIT CMV ANTIGENEMIA

Microbiology · 166d