Cleared Traditional

POLY-CHEM 90 GLUCOSE

K090703 · Polymedco, Inc. · Chemistry
Oct 2009
Decision
217d
Days
Class 2
Risk

About This 510(k) Submission

K090703 is an FDA 510(k) clearance for the POLY-CHEM 90 GLUCOSE, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on October 20, 2009, 217 days after receiving the submission on March 17, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K090703 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2009
Decision Date October 20, 2009
Days to Decision 217 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
K170316 · Abbott Laboratories · Oct 2017
ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II
K153644 · Elitechgroup · Sep 2016