Cleared Traditional

BLOOD GAS/ISE CONTROLS

K902094 · Phoenix Diagnostics, Inc. · Chemistry
Jul 1990
Decision
72d
Days
Class 1
Risk

About This 510(k) Submission

K902094 is an FDA 510(k) clearance for the BLOOD GAS/ISE CONTROLS, 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 July 19, 1990, 72 days after receiving the submission on May 8, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K902094 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 1990
Decision Date July 19, 1990
Days to Decision 72 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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