510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K120946Substantially Equivalent

Alpha Cryptococcal Antigen Eia

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

K120946 is the FDA 510(k) clearance record for ALPHA CRYPTOCOCCAL ANTIGEN EIA, a class II device, cleared for Immuno-Mycologics, Inc. on under FDA product code MDU (Antigen, Elisa, Cryptococcus). FDA records list 26 510(k) clearances for IMMY, Inc., from to . As of , FDA records show no recalls naming K120946.

Clearance record

Decision date
Received
(263 days to decision)
Product code
MDU Antigen, Elisa, Cryptococcus
Regulation
21 CFR 866.3165
Device class
Class II
Review panel
Microbiology
Applicant
Immuno-Mycologics, Inc. 116 S Crawford Ave., Norman OK
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MDU

Trailing 12 months

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

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