Cleared Traditional

ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP

K070146 · Horiba Abx · Chemistry
Oct 2007
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K070146 is an FDA 510(k) clearance for the ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP, a Urease And Glutamic Dehydrogenase, Urea Nitrogen (Class II — Special Controls, product code CDQ), submitted by Horiba Abx (Montpellier Cedex 4, FR). The FDA issued a Cleared decision on October 12, 2007, 269 days after receiving the submission on January 16, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K070146 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 2007
Decision Date October 12, 2007
Days to Decision 269 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDQ — Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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