Cleared Traditional

HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED

K911803 · Hichem Diagnostics · Chemistry
May 1991
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K911803 is an FDA 510(k) clearance for the HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on May 15, 1991, 22 days after receiving the submission on April 23, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K911803 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 1991
Decision Date May 15, 1991
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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