510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042629Substantially Equivalent

Varelisa Sm Antibodies, Model 18296

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

K042629 is the FDA 510(k) clearance record for VARELISA SM ANTIBODIES, MODEL 18296, a class II device, cleared for Sweden Diagnostics (Germany) GmbH on under FDA product code LKP (Anti-Sm Antibody, Antigen And Control). FDA records list 8 510(k) clearances for Sweden Diagnostics (Germany) GmbH, from to . As of , FDA records show no recalls naming K042629.

Clearance record

Decision date
Received
(72 days to decision)
Product code
LKP Anti-Sm Antibody, Antigen And Control
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 LKP

Trailing 12 months

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

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