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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 K120745
Device Name XN CAL
Original Applicant
STRECK
7002 south 109th st.
omaha,  NE  68128
Original Contact deborah s kipp
Regulation Number864.8150
Classification Product Code
KRX  
Date Received03/12/2012
Decision Date 10/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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