510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112422Substantially Equivalent

Crag Lateral Flow Assay (Lfa)

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

K112422 is the FDA 510(k) clearance record for CRAG LATERAL FLOW ASSAY (LFA), a class II device, cleared for Immuno-Mycologics, Inc. on under FDA product code GMD (Antisera, Latex Agglutination, Cryptococcus Neoformans). FDA records list 26 510(k) clearances for IMMY, Inc., from to . As of , FDA records show 3 recalls naming K112422.

Clearance record

Decision date
Received
(218 days to decision)
Product code
GMD Antisera, Latex Agglutination, Cryptococcus Neoformans
Regulation
21 CFR 866.3165
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 GMD

Trailing 12 months

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

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