Cleared Traditional

ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H

K070249 · Horiba Abx · Chemistry
Apr 2007
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K070249 is an FDA 510(k) clearance for the ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H, a Cresolphthalein Complexone, Calcium (Class II — Special Controls, product code CIC), submitted by Horiba Abx (Montpellier, FR). The FDA issued a Cleared decision on April 26, 2007, 90 days after receiving the submission on January 26, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K070249 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2007
Decision Date April 26, 2007
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIC — Cresolphthalein Complexone, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

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