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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 K053362
Device Name CELL-CHEX AUTO
Applicant
Streck
7002 SOUTH 109TH ST.
OMAHA,  NE  68128
Applicant Contact KERRIE OETTER
Correspondent
Streck
7002 SOUTH 109TH ST.
OMAHA,  NE  68128
Correspondent Contact KERRIE OETTER
Regulation Number864.8625
Classification Product Code
JPK  
Date Received12/02/2005
Decision Date 01/13/2006
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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