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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixture, Control, White-Cell And Red-Cell Indices
510(k) Number K101335
Device Name CELL-CHEX
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
GLQ  
Date Received05/12/2010
Decision Date 08/23/2010
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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