COAG-A-MATE MTX— 510(k) K962857

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K962857 for COAG-A-MATE MTX, Substantially Equivalent on 1997-01-22. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code GKP
Advisory panel: Hematology
Date received: 1996-07-22
Decision date: 1997-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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