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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K042485
Device Name TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Applicant Contact THERESA M AMBROSE
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Correspondent Contact THERESA M AMBROSE
Regulation Number866.5270
Classification Product Code
NQD  
Date Received09/13/2004
Decision Date 10/29/2004
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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