Cleared Traditional

QUANTIMETRIX BLOOD GLUCOSE CONTROLS

K932623 · Quantimetrix Corp. · Chemistry
Dec 1993
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K932623 is an FDA 510(k) clearance for the QUANTIMETRIX BLOOD GLUCOSE CONTROLS, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Quantimetrix Corp. (Hawthorne, US). The FDA issued a Cleared decision on December 9, 1993, 191 days after receiving the submission on June 1, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K932623 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 1993
Decision Date December 09, 1993
Days to Decision 191 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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