510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853540Substantially Equivalent

Fiax Test Kit for Varicella Antibody Serology

Idt, A Division of Whittaker M.A. Bioproducts, San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853540 is the FDA 510(k) clearance record for FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY, a class II device, cleared for Idt, A Division of Whittaker M.A. Bioproducts on under FDA product code GQX (Antiserum, Cf, Varicella-Zoster). FDA records list 5 510(k) clearances for Idt, A Division of Whittaker M.A. Bioproducts, from to . As of , FDA records show no recalls naming K853540.

Clearance record

Decision date
Received
(165 days to decision)
Product code
GQX Antiserum, Cf, Varicella-Zoster
Regulation
21 CFR 866.3900
Device class
Class II
Review panel
Microbiology
Applicant
Idt, A Division of Whittaker M.A. Bioproducts 2050 Concourse Dr., San Jose CA
Third party review
No

Clearances, product code GQX

Trailing 12 months

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

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