510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954831Substantially Equivalent

Orgentec Anti-Rnp/sm Pin Immuno Assay

Orgentec, Windham NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954831 is the FDA 510(k) clearance record for ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY, a class II device, cleared for Orgentec on under FDA product code LKO (Anti-Rnp Antibody, Antigen And Control). FDA records list 10 510(k) clearances for Orgentec, from to . As of , FDA records show no recalls naming K954831.

Clearance record

Decision date
Received
(201 days to decision)
Product code
LKO Anti-Rnp Antibody, Antigen And Control
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
Orgentec P.O. Box 451, Windham NH
510(k) summary
Statement
Third party review
No

Clearances, product code LKO

Trailing 12 months

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

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