510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101407Substantially Equivalent

Alpha Histoplasma Antigen Eia Model Hag102

IMMY, Inc., Norman OK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101407 is the FDA 510(k) clearance record for ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102, a class II device, cleared for Immuno-Mycologics, Inc. on under FDA product code MIZ (Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum). FDA records list 26 510(k) clearances for IMMY, Inc., from to . As of , FDA records show no recalls naming K101407.

Clearance record

Decision date
Received
(426 days to decision)
Product code
MIZ Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum
Regulation
21 CFR 866.3320
Device class
Class II
Review panel
Microbiology
Applicant
Immuno-Mycologics, Inc. 2700 Technology Pl., Norman OK
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MIZ

Trailing 12 months

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

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