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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
510(k) Number K241427
Device Name Access Syphilis
Applicant
Beckman Coulter, Inc
1000 Lake Hazeltine Drive
Chaska,  MN  55318
Applicant Contact Eifert Brenda
Correspondent
Beckman Coulter, Inc
1000 Lake Hazeltine Drive
Chaska,  MN  55318
Correspondent Contact Eifert Brenda
Regulation Number866.3830
Classification Product Code
LIP  
Date Received05/20/2024
Decision Date 09/06/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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