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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixture, Hematology Quality Control
510(k) Number K024173
Device Name CDS 3-PD HEMATOLOGY CONTROLS
Applicant
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
1660 N.W. 65TH AVE., SUITE 2
PLANTATION,  FL  33313
Applicant Contact ANDREW C SWANSON
Correspondent
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
1660 N.W. 65TH AVE., SUITE 2
PLANTATION,  FL  33313
Correspondent Contact ANDREW C SWANSON
Regulation Number864.8625
Classification Product Code
JPK  
Date Received12/18/2002
Decision Date 01/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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