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
K933575Substantially Equivalent

Virastat(r) Fitc-Label Anti-Parainflu 1,2&3 Mono Ant

Symex Corp., Tulsa OK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933575 is the FDA 510(k) clearance record for VIRASTAT(R) FITC-LABEL ANTI-PARAINFLU 1,2&3 MONO ANT, a class I device, cleared for Symex Corp. on under FDA product code GQP (Antisera, Neutralization, Parainfluenza Virus 1-4). FDA records list one 510(k) clearance for Symex Corp. As of , FDA records show no recalls naming K933575.

Clearance record

Decision date
Received
(493 days to decision)
Product code
GQP Antisera, Neutralization, Parainfluenza Virus 1-4
Regulation
21 CFR 866.3400
Device class
Class I
Review panel
Microbiology
Applicant
Symex Corp. P.O. Box 690355, Tulsa OK
510(k) summary
Statement
Third party review
No

Clearances, product code GQP

Trailing 12 months

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

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