510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K872733Substantially Equivalent

Fiax Test Kit for Mumps-G Antibodies

Whittaker Bioproducts, Inc., Walkersville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872733 is the FDA 510(k) clearance record for FIAX TEST KIT FOR MUMPS-G ANTIBODIES, a class I device, cleared for Whittaker Bioproducts, Inc. on under FDA product code GRB (Antiserum, Cf, Mumps Virus). FDA records list 30 510(k) clearances for Whittaker Bioproducts, Inc., from to . As of , FDA records show no recalls naming K872733.

Clearance record

Decision date
Received
(89 days to decision)
Product code
GRB Antiserum, Cf, Mumps Virus
Regulation
21 CFR 866.3380
Device class
Class I
Review panel
Microbiology
Applicant
Whittaker Bioproducts, Inc. 8830 Brigg Ford Rd., Walkersville MD
Third party review
No

Clearances, product code GRB

Trailing 12 months

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

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