Cleared Traditional

CLINICAL CHEMISTRY CONTROL

K904075 · Phoenix Diagnostics, Inc. · Chemistry
Dec 1990
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K904075 is an FDA 510(k) clearance for the CLINICAL CHEMISTRY CONTROL, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Phoenix Diagnostics, Inc. (Medfield, US). The FDA issued a Cleared decision on December 6, 1990, 93 days after receiving the submission on September 4, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K904075 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 1990
Decision Date December 06, 1990
Days to Decision 93 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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