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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 K234005
Device Name Access CK-MB
Applicant
Beckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact Neha Desai
Correspondent
Beckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact Neha Desai
Regulation Number862.1215
Classification Product Code
JHX  
Date Received12/19/2023
Decision Date 02/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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
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