510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904329Substantially Equivalent

Clostridium Difficile Toxin a Enzyme Immunoassay

Baxter Healthcare Corporation, Bellevue WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904329 is the FDA 510(k) clearance record for CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY, a class I device, cleared for Baxter Healthcare Corp on under FDA product code MCB (Antigen, C. Difficile). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K904329.

Clearance record

Decision date
Received
(173 days to decision)
Product code
MCB Antigen, C. Difficile
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Baxter Healthcare Corp P.O. Box 3093, Bellevue WA
Third party review
No

Clearances, product code MCB

Trailing 12 months

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

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