Cleared Traditional

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

K905385 · Virion (U.S.), Inc. · Microbiology

Mar 1991

Decision

111d

Days

Class 1

Risk

About This 510(k) Submission

K905385 is an FDA 510(k) clearance for the P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN, a Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4 (Class I — General Controls, product code GQS), submitted by Virion (U.S.), Inc. (Morristown, US). The FDA issued a Cleared decision on March 21, 1991, 111 days after receiving the submission on November 30, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3400.

Submission Details

510(k) Number	K905385 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 30, 1990
Decision Date	March 21, 1991
Days to Decision	111 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—