Cleared Traditional

SUPREME II METER

K963544 · Chronimed, Inc. · Chemistry
Feb 1997
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K963544 is an FDA 510(k) clearance for the SUPREME II METER, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Chronimed, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on February 20, 1997, 169 days after receiving the submission on September 4, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K963544 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 1996
Decision Date February 20, 1997
Days to Decision 169 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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