510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955134Substantially Equivalent

Orgentec Enascreen Elisa Assay

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

K955134 is the FDA 510(k) clearance record for ORGENTEC ENASCREEN ELISA ASSAY, a class II device, cleared for Orgentec on under FDA product code LLL (Extractable Antinuclear Antibody, Antigen And Control). FDA records list 10 510(k) clearances for Orgentec, from to . As of , FDA records show no recalls naming K955134.

Clearance record

Decision date
Received
(132 days to decision)
Product code
LLL Extractable Antinuclear 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 LLL

Trailing 12 months
2 clearances under product code LLL in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LLL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260