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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Uptake, Nuclear
510(k) Number K982442
Device Name C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)
Applicant
Care Wise Medical Products Corp.
P.O. Box 1655
Morgan Hill,  CA  95038
Applicant Contact ROBIN A WISE
Correspondent
Care Wise Medical Products Corp.
P.O. Box 1655
Morgan Hill,  CA  95038
Correspondent Contact ROBIN A WISE
Regulation Number892.1320
Classification Product Code
IZD  
Date Received07/14/1998
Decision Date 08/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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