EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME— 510(k) K890859

Substantially Equivalent

Elite Diagnostic , Ltd.

FDA 510(k) clearance K890859 for EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME, Substantially Equivalent on 1989-04-21. Applicant: Elite Diagnostic , Ltd..

Clearance details

Applicant
Elite Diagnostic , Ltd.
Product code
Code GFO
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Indianapolis, IN, US
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