Cleared Traditional

LIQUID CHEMISTRY CONTROL, LEVEL II

K870683 · U. S. Diagnostics, Inc. · Chemistry
Apr 1987
Decision
46d
Days
Class 1
Risk

About This 510(k) Submission

K870683 is an FDA 510(k) clearance for the LIQUID CHEMISTRY CONTROL, LEVEL II, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by U. S. Diagnostics, Inc. (San Luis Obispo, US). The FDA issued a Cleared decision on April 6, 1987, 46 days after receiving the submission on February 19, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K870683 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 1987
Decision Date April 06, 1987
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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