Cleared Traditional

GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT

K851703 · Miles Laboratories, Inc. · Chemistry
Aug 1985
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K851703 is an FDA 510(k) clearance for the GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on August 23, 1985, 121 days after receiving the submission on April 24, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K851703 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 1985
Decision Date August 23, 1985
Days to Decision 121 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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