FIBRINOSTIKA TDP MICROELISA SYSTEM— 510(k) K915698

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K915698 for FIBRINOSTIKA TDP MICROELISA SYSTEM, Substantially Equivalent on 1992-08-05. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code DAP
Advisory panel: Hematology
Date received: 1991-12-23
Decision date: 1992-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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