510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K792691Substantially Equivalent

Cryptococcus Neoformans, Antigen,

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

K792691 is the FDA 510(k) clearance record for CRYPTOCOCCUS NEOFORMANS, ANTIGEN,, a class II device, cleared for Meridian Diagnostics, Inc. on under FDA product code JWK (Antigen, Positive Control, Cryptococcus Neoformans). FDA records list 92 510(k) clearances for Meridian Diagnostics, Inc., from to . As of , FDA records show no recalls naming K792691.

Clearance record

Decision date
Received
(21 days to decision)
Product code
JWK Antigen, Positive Control, Cryptococcus Neoformans
Regulation
21 CFR 866.3165
Device class
Class II
Review panel
Microbiology
Applicant
Meridian Diagnostics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JWK

Trailing 12 months

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

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