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510(k) K050283

CREATININE LIQUICOLOR by Stanbio Laboratory — Product Code JFY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2005
Date Received
February 7, 2005
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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  • K020378 — QUPID PLUS E.R. (June 21, 2002)
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