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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C4, Antigen, Antiserum, Control
510(k) Number K012359
Device Name TINA-QUANT COMPLEMENT C4 TEST SYSTEM
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact HELEN T TORNEY
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact HELEN T TORNEY
Regulation Number866.5240
Classification Product Code
DBI  
Date Received07/25/2001
Decision Date 11/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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