Cleared Traditional

K853656 - QCA ENZYMATIC GLUCOSE (FDA 510(k) Clearance)

K853656 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
Sep 1985
Decision
13d
Days
Class 2
Risk

K853656 is an FDA 510(k) clearance for the QCA ENZYMATIC GLUCOSE. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Paramus, US). The FDA issued a Cleared decision on September 16, 1985, 13 days after receiving the submission on September 3, 1985.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K853656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1985
Decision Date September 16, 1985
Days to Decision 13 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