SERATEST ENA [SS-B] KIT— 510(k) K862700

Substantially Equivalent

Hemagen Diagnostics, Inc.

FDA 510(k) clearance K862700 for SERATEST ENA [SS-B] KIT, Substantially Equivalent on 1986-08-19. Applicant: Hemagen Diagnostics, Inc..

Clearance details

Applicant: Hemagen Diagnostics, Inc.
Product code: Code LLL
Advisory panel: Immunology
Date received: 1986-07-15
Decision date: 1986-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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