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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 K020129
Device Name PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE
Applicant
Phoenix Diagnostics, Inc.
8 Tech Cir.
Natick,  MA  01760
Applicant Contact RAM NUNNA
Correspondent
Phoenix Diagnostics, Inc.
8 Tech Cir.
Natick,  MA  01760
Correspondent Contact RAM NUNNA
Regulation Number862.1150
Classification Product Code
JIX  
Date Received01/14/2002
Decision Date 02/01/2002
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
Predetermined Change
Control Plan Authorized		 No
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