510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K791389Substantially Equivalent

Coccidioides Antigen #Cf10023x

IMMY, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K791389 is the FDA 510(k) clearance record for COCCIDIOIDES ANTIGEN #CF10023X, a class II device, cleared for Immuno-Mycologics, Inc. on under FDA product code GMI (Antigen, Cf And / Or Id, Coccidioides Immitis). FDA records list 26 510(k) clearances for IMMY, Inc., from to . As of , FDA records show no recalls naming K791389.

Clearance record

Decision date
Received
(36 days to decision)
Product code
GMI Antigen, Cf And / Or Id, Coccidioides Immitis
Regulation
21 CFR 866.3135
Device class
Class II
Review panel
Microbiology
Applicant
Immuno-Mycologics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GMI

Trailing 12 months

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

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