Cleared Traditional

SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI.

K864530 · Miles Laboratories, Inc. · Chemistry
Feb 1987
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K864530 is an FDA 510(k) clearance for the SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI., 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 February 18, 1987, 93 days after receiving the submission on November 17, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K864530 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 1986
Decision Date February 18, 1987
Days to Decision 93 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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