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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 K111211
Device Name CELL-DYN 22 PLUS CONTROL
Applicant
Streck
7002 SOUTH 109TH ST.
omaha,  NE  68128
Applicant Contact deborah kipp
Correspondent
Streck
7002 SOUTH 109TH ST.
omaha,  NE  68128
Correspondent Contact deborah kipp
Regulation Number864.8625
Classification Product Code
GLQ  
Date Received04/29/2011
Decision Date 12/22/2011
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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