FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM— 510(k) K924892

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K924892 for FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM, Substantially Equivalent on 1994-04-21. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code DAT
Advisory panel: Hematology
Date received: 1992-09-29
Decision date: 1994-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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