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510(k) K071779

ABX PENTRA URINE CAL by Horiba Abx — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2008
Date Received
July 2, 2007
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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  • K123321 — DIMENSION CHEMISTRY III CALIBRATORY (February 15, 2013)
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