510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132631Substantially Equivalent

Eia Smdp Immunoassay

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

K132631 is the FDA 510(k) clearance record for EIA SMDP IMMUNOASSAY, a class II device, cleared for Phadia US, Inc. 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 one recall naming K132631.

Clearance record

Decision date
Received
(372 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 US, Inc. 4169 Commercial Ave., Portage MI
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