Cleared Traditional

PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS

K020364 · Phoenix Diagnostics, Inc. · Chemistry
Jun 2002
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K020364 is an FDA 510(k) clearance for the PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Phoenix Diagnostics, Inc. (Natick, US). The FDA issued a Cleared decision on June 4, 2002, 120 days after receiving the submission on February 4, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K020364 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2002
Decision Date June 04, 2002
Days to Decision 120 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JGS — Electrode, Ion Specific, Sodium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1665

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