Cleared Abbreviated

ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT

K123171 · HORIBA ABX SAS · Chemistry
Jul 2013
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K123171 is an FDA 510(k) clearance for the ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT, a Azo Dye, Calcium (Class II — Special Controls, product code CJY), submitted by HORIBA ABX SAS (Montpellier, FR). The FDA issued a Cleared decision on July 3, 2013, 267 days after receiving the submission on October 9, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K123171 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 2012
Decision Date July 03, 2013
Days to Decision 267 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CJY — Azo Dye, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

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