Cleared Traditional

ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)

K902266 · Phoenix Diagnostics, Inc. · Chemistry
Jun 1990
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K902266 is an FDA 510(k) clearance for the ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED), a Electrolyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJR), submitted by Phoenix Diagnostics, Inc. (Medfield, US). The FDA issued a Cleared decision on June 6, 1990, 16 days after receiving the submission on May 21, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K902266 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 1990
Decision Date June 06, 1990
Days to Decision 16 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJR — Electrolyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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