510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050967Substantially Equivalent

Varelisa Recombi Ctd Screen, Model 13096

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

K050967 is the FDA 510(k) clearance record for VARELISA RECOMBI CTD SCREEN, MODEL 13096, a class II device, cleared for Sweden Diagnostics (Germany) GmbH on under FDA product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls). FDA records list 8 510(k) clearances for Sweden Diagnostics (Germany) GmbH, from to . As of , FDA records show no recalls naming K050967.

Clearance record

Decision date
Received
(71 days to decision)
Product code
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Regulation
21 CFR 866.5100
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 LJM

Trailing 12 months

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

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