510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K041040Substantially Equivalent

Varelisa Mpo Anca, Model 17648/17696

Sweden Diagnostics (Germany) GmbH, Freiburg, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041040 is the FDA 510(k) clearance record for VARELISA MPO ANCA, MODEL 17648/17696, a class II device, cleared for Sweden Diagnostics (Germany) GmbH on under FDA product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)). FDA records list 8 510(k) clearances for Sweden Diagnostics (Germany) GmbH, from to . As of , FDA records show no recalls naming K041040.

Clearance record

Decision date
Received
(55 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
Sweden Diagnostics (Germany) GmbH Munzingerstrasse 7, Freiburg, DE
510(k) summary
Summary PDF
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