510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894261Substantially Equivalent

Toxoplasma Gondii-Cf Antigen and Control Antigen

Microbix Biosystems, Inc., Flemington NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894261 is the FDA 510(k) clearance record for TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN, a class II device, cleared for Microbix Biosystems, Inc. on under FDA product code GMN (Antigens, Cf, Toxoplasma Gondii). FDA records list 7 510(k) clearances for Microbix Biosystems, Inc., from to . As of , FDA records show no recalls naming K894261.

Clearance record

Decision date
Received
(117 days to decision)
Product code
GMN Antigens, Cf, Toxoplasma Gondii
Regulation
21 CFR 866.3780
Device class
Class II
Review panel
Microbiology
Applicant
Microbix Biosystems, Inc. Darts Mill, Flemington NJ
Third party review
No

Clearances, product code GMN

Trailing 12 months

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

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