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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 K051706
Device Name IQ BODY FLUIDS CONTROL
Applicant
Streck
7002 S 109th St.
La Vista,  NE  68128
Applicant Contact MARK LEWALLEN
Correspondent
Streck
7002 S 109th St.
La Vista,  NE  68128
Correspondent Contact MARK LEWALLEN
Regulation Number864.8625
Classification Product Code
JPK  
Date Received06/27/2005
Decision Date 08/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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