510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K792687Substantially Equivalent

Aspergillus Sp., Antigen

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

K792687 is the FDA 510(k) clearance record for ASPERGILLUS SP., ANTIGEN, a class II device, cleared for Meridian Diagnostics, Inc. on under FDA product code JWI (Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained). FDA records list 92 510(k) clearances for Meridian Diagnostics, Inc., from to . As of , FDA records show no recalls naming K792687.

Clearance record

Decision date
Received
(21 days to decision)
Product code
JWI Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained
Regulation
21 CFR 888.3800
Device class
Class II
Review panel
Orthopedic
Applicant
Meridian Diagnostics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JWI

Trailing 12 months

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

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