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510(k) K010456

BIOSCANNER CREATININE TEST STRIPS by Polymer Technology Systems, Inc. — Product Code JFY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2001
Date Received
February 16, 2001
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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