Cleared Traditional

VISUAL BLOOD GLUCOSE TEST SYSTEM

K884993 · Diagnostic Systems · Chemistry
Dec 1988
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K884993 is an FDA 510(k) clearance for the VISUAL BLOOD GLUCOSE TEST SYSTEM, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Diagnostic Systems (Rock Hill, US). The FDA issued a Cleared decision on December 29, 1988, 28 days after receiving the submission on December 1, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K884993 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 1988
Decision Date December 29, 1988
Days to Decision 28 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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