THROMBONOSTIKA F1.2— 510(k) K964934

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K964934 for THROMBONOSTIKA F1.2, Substantially Equivalent on 1997-03-18. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code MIF
Advisory panel: Hematology
Date received: 1996-12-09
Decision date: 1997-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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