SERATEST ENA [SCL-70] KIT— 510(k) K894411

Substantially Equivalent

Hemagen Diagnostics, Inc.

FDA 510(k) clearance K894411 for SERATEST ENA [SCL-70] KIT, Substantially Equivalent on 1989-08-02. Applicant: Hemagen Diagnostics, Inc..

Clearance details

Applicant: Hemagen Diagnostics, Inc.
Product code: Code LKJ
Advisory panel: Immunology
Date received: 1989-07-17
Decision date: 1989-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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