510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984596Substantially Equivalent

Virastat Fitc-Labeled Anti-Influenza a and B Monoclonal Antibodies

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

K984596 is the FDA 510(k) clearance record for VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES, a class I device, cleared for Zymetx, Inc. on under FDA product code GNR (Antisera, Neutralization, 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 K984596.

Clearance record

Decision date
Received
(66 days to decision)
Product code
GNR Antisera, Neutralization, Influenza Virus A, B, C
Regulation
21 CFR 866.3330
Device class
Class I
Review panel
Microbiology
Applicant
Zymetx, Inc. 800 Research Pkwy., Suite 100, Oklahoma City OK
510(k) summary
Summary
Third party review
No

Clearances, product code GNR

Trailing 12 months

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

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