MDA D-DIMER— 510(k) K974776

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K974776 for MDA D-DIMER, Substantially Equivalent on 1998-04-16. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code DAP
Advisory panel: Hematology
Date received: 1997-12-22
Decision date: 1998-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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