510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K760832Substantially Equivalent

Anti-Histoplasma Control Serum (Yeast)

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

K760832 is the FDA 510(k) clearance record for ANTI-HISTOPLASMA CONTROL SERUM (YEAST), a class II device, cleared for I M, Inc. on under FDA product code GMK (Antiserum, Positive Control, Histoplasma Capsulatum). FDA records list 26 510(k) clearances for I M, Inc., from to . As of , FDA records show no recalls naming K760832.

Clearance record

Decision date
Received
(19 days to decision)
Product code
GMK Antiserum, Positive Control, Histoplasma Capsulatum
Regulation
21 CFR 866.3320
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 GMK

Trailing 12 months

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

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