Cleared Abbreviated

ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN

K110137 · HORIBA ABX SAS · Chemistry

Aug 2011

Decision

204d

Days

Class 2

Risk

About This 510(k) Submission

K110137 is an FDA 510(k) clearance for the ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN, a Enzymatic Method, Creatinine (Class II — Special Controls, product code JFY), submitted by HORIBA ABX SAS (Montpellier, FR). The FDA issued a Cleared decision on August 10, 2011, 204 days after receiving the submission on January 18, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number	K110137 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 18, 2011
Decision Date	August 10, 2011
Days to Decision	204 days
Submission Type	Abbreviated
Review Panel	Chemistry (CH)
Summary	Summary PDF