HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)— 510(k) K915272

Substantially Equivalent

Hemagen Diagnostics, Inc.

FDA 510(k) clearance K915272 for HEMAGEN ENA [RNP/SM] KIT (EIA METHOD), Substantially Equivalent on 1992-03-17. Applicant: Hemagen Diagnostics, Inc..

Clearance details

Applicant: Hemagen Diagnostics, Inc.
Product code: Code LJM
Advisory panel: Immunology
Date received: 1991-11-25
Decision date: 1992-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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