COAG-A-MATE(R) XM— 510(k) K881281

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K881281 for COAG-A-MATE(R) XM, Substantially Equivalent on 1988-05-18. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code GKP
Advisory panel: Hematology
Date received: 1988-03-25
Decision date: 1988-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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