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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Albumin, Antigen, Antiserum, Control
510(k) Number K101203
Device Name TINA-QUANT ALBUMIN GEN 2
Applicant
Roche Diagnostics
9115 HAGUE RD
INDIANAPOLIS,  IN  46250
Applicant Contact KATHIE J GOODWIN
Correspondent
Roche Diagnostics
9115 HAGUE RD
INDIANAPOLIS,  IN  46250
Correspondent Contact KATHIE J GOODWIN
Regulation Number866.5040
Classification Product Code
DCF  
Date Received04/29/2010
Decision Date 09/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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