510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K760834Substantially Equivalent

Anti-Coccidioides Cont. Ser. (Mycelial)

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

K760834 is the FDA 510(k) clearance record for ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL), a class II device, cleared for I M, Inc. on under FDA product code GMH (Antiserum, Positive Control, Coccidioides Immitis). FDA records list 26 510(k) clearances for I M, Inc., from to . As of , FDA records show no recalls naming K760834.

Clearance record

Decision date
Received
(19 days to decision)
Product code
GMH Antiserum, Positive Control, Coccidioides Immitis
Regulation
21 CFR 866.3135
Device class
Class II
Review panel
Microbiology
Applicant
I M, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GMH

Trailing 12 months

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

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