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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometric Method, Cpk Or Isoenzymes
510(k) Number K030012
Device Name CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372
Applicant
Beckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318 -1084
Applicant Contact BRENT TABER
Correspondent
Beckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318 -1084
Correspondent Contact BRENT TABER
Regulation Number862.1215
Classification Product Code
JHX  
Subsequent Product Code
JIS  
Date Received01/02/2003
Decision Date 01/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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