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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igm (Mu Chain Specific), Antigen, Antiserum, Control
510(k) Number K040431
Device Name ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact SHERRI L COENEN
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact SHERRI L COENEN
Regulation Number866.5550
Classification Product Code
DAO  
Date Received02/19/2004
Decision Date 03/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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