Cleared Traditional

pHoenix ISE Reagents FOR Olympus AU Chemistry Systems

K020148 · Phoenix Diagnostics, Inc. · Chemistry
Feb 2002
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K020148 is an FDA 510(k) clearance for the pHoenix ISE Reagents FOR Olympus AU Chemistry Systems, a Electrode, Ion-specific, Chloride (Class II — Special Controls, product code CGZ), submitted by Phoenix Diagnostics, Inc. (Natick, US). The FDA issued a Cleared decision on February 4, 2002, 19 days after receiving the submission on January 16, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K020148 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 2002
Decision Date February 04, 2002
Days to Decision 19 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGZ — Electrode, Ion-specific, Chloride
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1170

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