ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY— 510(k) K954831

Substantially Equivalent

Orgentec

FDA 510(k) clearance K954831 for ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY, Substantially Equivalent on 1996-05-08. Applicant: Orgentec.

Clearance details

Applicant: Orgentec
Product code: Code LKO
Advisory panel: Immunology
Date received: 1995-10-20
Decision date: 1996-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Windham, NH, US

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