510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904393Substantially Equivalent

Premier-Cryptococcal Antigen

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

K904393 is the FDA 510(k) clearance record for PREMIER-CRYPTOCOCCAL ANTIGEN, a class II device, cleared for Meridian Diagnostics, Inc. on under FDA product code MDU (Antigen, Elisa, Cryptococcus). FDA records list 92 510(k) clearances for Meridian Diagnostics, Inc., from to . As of , FDA records show one recall naming K904393.

Clearance record

Decision date
Received
(122 days to decision)
Product code
MDU Antigen, Elisa, Cryptococcus
Regulation
21 CFR 866.3165
Device class
Class II
Review panel
Microbiology
Applicant
Meridian Diagnostics, Inc. 3471 River Hills Dr., Cincinnati OH
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