ORGENTEC ENASCREEN PIN IMMUNO ASSAY— 510(k) K955133

Substantially Equivalent

Orgentec

FDA 510(k) clearance K955133 for ORGENTEC ENASCREEN PIN IMMUNO ASSAY, Substantially Equivalent on 1996-03-20. Applicant: Orgentec.

Clearance details

Applicant: Orgentec
Product code: Code LLL
Advisory panel: Immunology
Date received: 1995-11-09
Decision date: 1996-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Windham, NH, US

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