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510(k) K081276

ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H by Horiba Abx — Product Code CFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2008
Date Received
May 5, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hexokinase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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