HEMAGEN ENA [JO-I] KIT— 510(k) K902139

Substantially Equivalent

Hemagen Diagnostics, Inc.

FDA 510(k) clearance K902139 for HEMAGEN ENA [JO-I] KIT, Substantially Equivalent on 1990-05-18. Applicant: Hemagen Diagnostics, Inc..

Clearance details

Applicant: Hemagen Diagnostics, Inc.
Product code: Code DHN
Advisory panel: Immunology
Date received: 1990-05-09
Decision date: 1990-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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