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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, White-Cell
510(k) Number K083926
Device Name CD4 COUNT
Applicant
Streck
7002 S. 109th St.
La Vista,  NE  68128
Applicant Contact KERRIE OETTER
Correspondent
Streck
7002 S. 109th St.
La Vista,  NE  68128
Correspondent Contact KERRIE OETTER
Regulation Number864.8625
Classification Product Code
GGL  
Date Received12/31/2008
Decision Date 02/11/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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