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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Myoglobin, Antigen, Antiserum, Control
510(k) Number K061683
Device Name TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact THERESA AMBROSE BUSH
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact THERESA AMBROSE BUSH
Regulation Number866.5680
Classification Product Code
DDR  
Subsequent Product Code
JIT  
Date Received06/15/2006
Decision Date 07/21/2006
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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