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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 K021229
Device Name MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244
Applicant
Beckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318 -1084
Applicant Contact BRUCE BACKLUND
Correspondent
Beckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318 -1084
Correspondent Contact BRUCE BACKLUND
Regulation Number866.5680
Classification Product Code
DDR  
Subsequent Product Code
JIS  
Date Received04/18/2002
Decision Date 06/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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