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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator For Hemoglobin And Hematocrit Measurement
510(k) Number K041130
Device Name CDS HEMATOLOGY CALIBRATOR (CDS CAL)
Applicant
Clinical Diagnostic Solutions, Inc.
1660 NW 65th Ave. Suite 2
Plantation,  FL  33313
Applicant Contact ANDREW SWANSON
Correspondent
Clinical Diagnostic Solutions, Inc.
1660 NW 65th Ave. Suite 2
Plantation,  FL  33313
Correspondent Contact ANDREW SWANSON
Regulation Number864.8165
Classification Product Code
KRZ  
Subsequent Product Codes
KRY   KSA  
Date Received04/30/2004
Decision Date 06/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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