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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control Material, Her-2/Neu, Immunohistochemistry
510(k) Number K023335
Device Name QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)
Applicant
Qc Sciences, LLC
2807 N. Parham
Suite 114
Richmond,  VA  23294
Applicant Contact JUNQI QIAN
Correspondent
Qc Sciences, LLC
2807 N. Parham
Suite 114
Richmond,  VA  23294
Correspondent Contact JUNQI QIAN
Regulation Number864.1860
Classification Product Code
NJW  
Date Received10/07/2002
Decision Date 06/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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