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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, T Lymphocyte Surface Marker
510(k) Number K833929
Device Name WHITE BLOOD CELLS HUMAN TAND B
Applicant
Control Diagnostics
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Control Diagnostics
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.5220
Classification Product Code
LIZ  
Date Received10/18/1983
Decision Date 02/03/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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