510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053012Substantially Equivalent

Fidis Vasculitis, Model Mx007

Biomedical Diagnostics (Bmd) SA, Marne La Vallee Cedex 2, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K053012 is the FDA 510(k) clearance record for FIDIS VASCULITIS, MODEL MX007, a class II device, cleared for Biomedical Diagnostics (Bmd) SA on under FDA product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)). FDA records list 10 510(k) clearances for Biomedical Diagnostics (Bmd) SA, from to . As of , FDA records show no recalls naming K053012.

Clearance record

Decision date
Received
(127 days to decision)
Product code
MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Biomedical Diagnostics (Bmd) SA Actipole 25, Marne La Vallee Cedex 2, FR
510(k) summary
Statement
Third party review
No

Clearances, product code MOB

Trailing 12 months
1 clearance under product code MOB in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MOB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260