510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202067Substantially Equivalent

EliA SmDP-S

Phadia AB, Uppsala, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202067 is the FDA 510(k) clearance record for EliA SmDP-S, a class II device, cleared for Phadia AB on under FDA product code LKP (Anti-Sm Antibody, Antigen And Control). FDA records list 56 510(k) clearances for Phadia AB, from to . As of , FDA records show no recalls naming K202067.

Clearance record

Decision date
Received
(352 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
Phadia AB Rapsgatan 7p, Uppsala, SE
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