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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 -0457
Applicant Contact HELEN T TORNEY
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250 -0457
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
Recalls CDRH Recalls
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