THROMBONOSTIKA F1.2— 510(k) K911434

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K911434 for THROMBONOSTIKA F1.2, Substantially Equivalent on 1991-10-31. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code MIF
Advisory panel: Hematology
Date received: 1991-04-02
Decision date: 1991-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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