Cleared Traditional

ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM

K170316 · Abbott Laboratories · Chemistry
Oct 2017
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K170316 is an FDA 510(k) clearance for the ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 19, 2017, 260 days after receiving the submission on February 1, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K170316 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2017
Decision Date October 19, 2017
Days to Decision 260 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

Similar Devices — CFR Hexokinase, Glucose

All 144
Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions
K253490 · Roche Diagnostics · Feb 2026
Glucose2
K252357 · Abbott Ireland · Oct 2025
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
K220134 · Roche Diagnostics · Sep 2022
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
K191899 · Roche Diagnostics · Aug 2019
ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II
K153644 · Elitechgroup · Sep 2016
Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method
K151487 · Diatron U.S., Inc. · Jan 2016