510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K791390Substantially Equivalent

Anti-Blastomyces Serum #Cf10027x

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

K791390 is the FDA 510(k) clearance record for ANTI-BLASTOMYCES SERUM #CF10027X, a class II device, cleared for Immuno-Mycologics, Inc. on under FDA product code GMK (Antiserum, Positive Control, Histoplasma Capsulatum). FDA records list 26 510(k) clearances for IMMY, Inc., from to . As of , FDA records show no recalls naming K791390.

Clearance record

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