EDL NORMAL COAGULATION CONTROL— 510(k) K891179

Substantially Equivalent

Elite Diagnostic , Ltd.

FDA 510(k) clearance K891179 for EDL NORMAL COAGULATION CONTROL, Substantially Equivalent on 1989-04-10. Applicant: Elite Diagnostic , Ltd..

Clearance details

Applicant: Elite Diagnostic , Ltd.
Product code: Code GIZ
Advisory panel: Hematology
Date received: 1989-03-06
Decision date: 1989-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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