Cleared Traditional

PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER

K012987 · Phoenix Diagnostics, Inc. · Chemistry
Nov 2001
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K012987 is an FDA 510(k) clearance for the PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER, 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 November 7, 2001, 62 days after receiving the submission on September 6, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K012987 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2001
Decision Date November 07, 2001
Days to Decision 62 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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