Cleared Traditional

PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT

K103788 · HORIBA ABX SAS · Chemistry
Nov 2011
Decision
316d
Days
Class 2
Risk

About This 510(k) Submission

K103788 is an FDA 510(k) clearance for the PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by HORIBA ABX SAS (Montpellier, FR). The FDA issued a Cleared decision on November 8, 2011, 316 days after receiving the submission on December 27, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K103788 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2010
Decision Date November 08, 2011
Days to Decision 316 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CFR — Hexokinase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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