510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861716Substantially Equivalent

Fiax Test Kit for Mycoplasma Pneumoniae-G Antibody

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

K861716 is the FDA 510(k) clearance record for FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY, a class I device, cleared for Whittaker Bioproducts, Inc. on under FDA product code GRZ (Antisera, Fluorescent, All, Mycoplasma Spp.). FDA records list 30 510(k) clearances for Whittaker Bioproducts, Inc., from to . As of , FDA records show no recalls naming K861716.

Clearance record

Decision date
Received
(94 days to decision)
Product code
GRZ Antisera, Fluorescent, All, Mycoplasma Spp.
Regulation
21 CFR 866.3375
Device class
Class I
Review panel
Microbiology
Applicant
Whittaker Bioproducts, Inc. 8830 Brigg Ford Rd., Walkersville MD
Third party review
No

Clearances, product code GRZ

Trailing 12 months

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

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