510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953671Substantially Equivalent

Orgen Tec Anti-Dsdna Elisa Assay

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

K953671 is the FDA 510(k) clearance record for ORGEN TEC ANTI-DSDNA ELISA ASSAY, a class II device, cleared for Orgentec on under FDA product code LRM (Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control). FDA records list 10 510(k) clearances for Orgentec, from to . As of , FDA records show no recalls naming K953671.

Clearance record

Decision date
Received
(94 days to decision)
Product code
LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, 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 LRM

Trailing 12 months

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

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