Medical Device Manufacturer · US , Morristown , NJ

Virion (U.S.), Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1987

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Virion (U.S.), Inc. Microbiology ✕

5 devices

1-5 of 5

Cleared Jun 13, 1994

EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST

Microbiology · 346d

Cleared Jun 29, 1992

COXSACKIE VIRUS B1-B6 CF ANTIGENS

Microbiology · 84d

Cleared Jun 17, 1991

MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN

Microbiology · 201d

Cleared Mar 21, 1991

P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN

Microbiology · 111d

Cleared Oct 30, 1987

TOXOPLASMA GONDII

Microbiology · 312d