Cleared Traditional

HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL

K913792 · Hichem Diagnostics · Chemistry
Sep 1991
Decision
33d
Days
Class 1
Risk

About This 510(k) Submission

K913792 is an FDA 510(k) clearance for the HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on September 25, 1991, 33 days after receiving the submission on August 23, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K913792 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 1991
Decision Date September 25, 1991
Days to Decision 33 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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