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510(k) K072115

ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H by Horiba Abx — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2007
Date Received
August 1, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

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