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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 K972513
Device Name TINAQUANT MYOGLOBIN ASSAY
Applicant
Boehringer Mannheim Corp.
2400 Bisso Ln.
Concord,  CA  94524
Applicant Contact Yvette Lloyd
Correspondent
Boehringer Mannheim Corp.
2400 Bisso Ln.
Concord,  CA  94524
Correspondent Contact Yvette Lloyd
Regulation Number866.5680
Classification Product Code
DDR  
Date Received07/07/1997
Decision Date 07/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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