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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K012987
Device Name PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER
Applicant
PHOENIX DIAGNOSTICS, INC.
8 TECH CIRCLE
NATICK,  MA  01760
Applicant Contact RAM NUNNA
Correspondent
PHOENIX DIAGNOSTICS, INC.
8 TECH CIRCLE
NATICK,  MA  01760
Correspondent Contact RAM NUNNA
Regulation Number862.1150
Classification Product Code
JIX  
Date Received09/06/2001
Decision Date 11/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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