Cleared Traditional

SUGAR CHEX ONE

K001443 · Streck Laboratories, Inc. · Chemistry
Jun 2000
Decision
52d
Days
Class 1
Risk

About This 510(k) Submission

K001443 is an FDA 510(k) clearance for the SUGAR CHEX ONE, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on June 29, 2000, 52 days after receiving the submission on May 8, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K001443 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2000
Decision Date June 29, 2000
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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