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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator For Cell Indices
510(k) Number K120747
Device Name XN CAL PF
Applicant
Streck
7002 S. 109th St.
La Vista,  NE  68128
Applicant Contact DEBORAH S KIPP
Correspondent
Streck
7002 S. 109th St.
La Vista,  NE  68128
Correspondent Contact DEBORAH S KIPP
Regulation Number864.8150
Classification Product Code
KRX  
Date Received03/12/2012
Decision Date 10/22/2012
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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