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510(k) K132399

ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL by Elitechgroup — Product Code JFY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2014
Date Received
August 1, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Method, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

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