HEMAGEN ENA SCREENING KIT— 510(k) K910232

Substantially Equivalent

Hemagen Diagnostics, Inc.

FDA 510(k) clearance K910232 for HEMAGEN ENA SCREENING KIT, Substantially Equivalent on 1991-03-06. Applicant: Hemagen Diagnostics, Inc..

Clearance details

Applicant: Hemagen Diagnostics, Inc.
Product code: Code LLL
Advisory panel: Immunology
Date received: 1991-01-18
Decision date: 1991-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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