Cleared Traditional

ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II

K153644 · Elitechgroup · Chemistry
Sep 2016
Decision
261d
Days
Class 2
Risk

About This 510(k) Submission

K153644 is an FDA 510(k) clearance for the ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Elitechgroup (Sees, FR). The FDA issued a Cleared decision on September 7, 2016, 261 days after receiving the submission on December 21, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K153644 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2015
Decision Date September 07, 2016
Days to Decision 261 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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