Cleared Traditional

PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE

K020129 · Phoenix Diagnostics, Inc. · Chemistry
Feb 2002
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K020129 is an FDA 510(k) clearance for the PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Phoenix Diagnostics, Inc. (Natick, US). The FDA issued a Cleared decision on February 1, 2002, 18 days after receiving the submission on January 14, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K020129 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 2002
Decision Date February 01, 2002
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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