510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950838Substantially Equivalent

Virazyme Culture Confirmation Screen for Influenza and Parainfluenza Viruses

Zymetx, Inc., Oklahoma City OK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950838 is the FDA 510(k) clearance record for VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES, a class I device, cleared for Zymetx, Inc. on under FDA product code GNT (Antigens, Ha (Including Ha Control), Influenza Virus A, B, C). FDA records list 4 510(k) clearances for Zymetx, Inc., from to . As of , FDA records show no recalls naming K950838.

Clearance record

Decision date
Received
(479 days to decision)
Product code
GNT Antigens, Ha (Including Ha Control), Influenza Virus A, B, C
Regulation
21 CFR 866.3330
Device class
Class I
Review panel
Microbiology
Applicant
Zymetx, Inc. 25 Northwest 4th St., Oklahoma City OK
510(k) summary
Summary
Third party review
No

Clearances, product code GNT

Trailing 12 months

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

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