510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K843660Substantially Equivalent

In Fluenza B Virus

Institute Virion, Ltd., Oakland CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843660 is the FDA 510(k) clearance record for IN FLUENZA B VIRUS, a class I device, cleared for Institute Virion , Ltd. on under FDA product code GNX (Antigens, Cf (Including Cf Control), Influenza Virus A, B, C). FDA records list 16 510(k) clearances for Institute Virion , Ltd., from to . As of , FDA records show no recalls naming K843660.

Clearance record

Decision date
Received
(374 days to decision)
Product code
GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Regulation
21 CFR 866.3330
Device class
Class I
Review panel
Microbiology
Applicant
Institute Virion , Ltd. 6605 Ascot Dr., Oakland CA
Third party review
No

Clearances, product code GNX

Trailing 12 months

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

FDA records show no clearances under product code GNX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GNX, 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