510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905385Substantially Equivalent

P.i.v. Complement-Fixation (C.f.) Antigen

Virion (U.S.), Inc., Morristown NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905385 is the FDA 510(k) clearance record for P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN, a class I device, cleared for Virion (U.S.), Inc. on under FDA product code GQS (Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4). FDA records list 5 510(k) clearances for Virion (U.S.), Inc., from to . As of , FDA records show no recalls naming K905385.

Clearance record

Decision date
Received
(111 days to decision)
Product code
GQS Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
Regulation
21 CFR 866.3400
Device class
Class I
Review panel
Microbiology
Applicant
Virion (U.S.), Inc. 4 Upperfield Rd., Morristown NJ
Third party review
No

Clearances, product code GQS

Trailing 12 months

FDA records hold no clearances under product code GQS in the trailing twelve months.

FDA records show no clearances under product code GQS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GQS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260