HEMOCHRON ONESTEP APTT TEST— 510(k) K915344

Substantially Equivalent

International Technidyne Corp.

FDA 510(k) clearance K915344 for HEMOCHRON ONESTEP APTT TEST, Substantially Equivalent on 1992-02-11. Applicant: International Technidyne Corp..

Clearance details

Applicant: International Technidyne Corp.
Product code: Code GFO
Advisory panel: Hematology
Date received: 1991-11-26
Decision date: 1992-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

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