Cleared Traditional

HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH

K941433 · Hichem Diagnostics · Chemistry
Aug 1994
Decision
131d
Days
Class 1
Risk

About This 510(k) Submission

K941433 is an FDA 510(k) clearance for the HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH, 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 August 2, 1994, 131 days after receiving the submission on March 24, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K941433 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1994
Decision Date August 02, 1994
Days to Decision 131 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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