HEMOCHRON RESPONSE— 510(k) K983475

Substantially Equivalent

International Technidyne Corp.

FDA 510(k) clearance K983475 for HEMOCHRON RESPONSE, Substantially Equivalent on 1999-05-03. Applicant: International Technidyne Corp..

Clearance details

Applicant: International Technidyne Corp.
Product code: Code KQG
Advisory panel: Hematology
Date received: 1998-10-02
Decision date: 1999-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

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