ORGEN TEC ANTI-DSDNA ELISA ASSAY— 510(k) K953671

Substantially Equivalent

Orgentec

FDA 510(k) clearance K953671 for ORGEN TEC ANTI-DSDNA ELISA ASSAY, Substantially Equivalent on 1995-11-09. Applicant: Orgentec. Device class: 2.

Clearance details

Applicant: Orgentec
Product code: Code LRM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1995-08-07
Decision date: 1995-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Windham, NH, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.