Cleared Traditional

GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT

K871835 · Miles Laboratories, Inc. · Chemistry
Dec 1987
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K871835 is an FDA 510(k) clearance for the GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT, 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 December 22, 1987, 225 days after receiving the submission on May 11, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K871835 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 1987
Decision Date December 22, 1987
Days to Decision 225 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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