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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 SOUTH 109TH ST.
OMAHA,  NE  68128
Applicant Contact DEBORAH S KIPP
Correspondent
Streck
7002 SOUTH 109TH ST.
OMAHA,  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
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