ORGENTEC ENASCREEN ELISA ASSAY— 510(k) K955134

Substantially Equivalent

Orgentec

FDA 510(k) clearance K955134 for ORGENTEC ENASCREEN ELISA ASSAY, Substantially Equivalent on 1996-03-20. Applicant: Orgentec. Device class: 2.

Clearance details

Applicant: Orgentec
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1995-11-09
Decision date: 1996-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Windham, NH, US

Download summary PDF View on FDA.gov ↗

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