510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K792679Substantially Equivalent

Histoplasma Capsulatum, Antiserum

Meridian Diagnostics, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K792679 is the FDA 510(k) clearance record for HISTOPLASMA CAPSULATUM, ANTISERUM, a class II device, cleared for Meridian Diagnostics, Inc. on under FDA product code GMK (Antiserum, Positive Control, Histoplasma Capsulatum). FDA records list 92 510(k) clearances for Meridian Diagnostics, Inc., from to . As of , FDA records show no recalls naming K792679.

Clearance record

Decision date
Received
(21 days to decision)
Product code
GMK Antiserum, Positive Control, Histoplasma Capsulatum
Regulation
21 CFR 866.3320
Device class
Class II
Review panel
Microbiology
Applicant
Meridian Diagnostics, Inc. 4221 Richmond Rd., NW, Walker MI
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