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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K050436
Device Name MS 9/5 HEMATOLOGY ANALYZER
Applicant
Melet Schloesing Laboratories USA
7703 Convoy Ct.
San Diego,  CA  92111
Applicant Contact JACKIE COLEMAN
Correspondent
Melet Schloesing Laboratories USA
7703 Convoy Ct.
San Diego,  CA  92111
Correspondent Contact JACKIE COLEMAN
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received02/22/2005
Decision Date 07/27/2005
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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