Cleared Abbreviated

K110530 - ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL
(FDA 510(k) Clearance)

K110530 · HORIBA ABX SAS · Chemistry

Apr 2012

Decision

431d

Days

Class 2

Risk

K110530 is an FDA 510(k) clearance for the ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by HORIBA ABX SAS (Montpellier, FR). The FDA issued a Cleared decision on April 30, 2012, 431 days after receiving the submission on February 24, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number	K110530 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 2011
Decision Date	April 30, 2012
Days to Decision	431 days
Submission Type	Abbreviated
Review Panel	Chemistry (CH)
Summary	Summary PDF