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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Method, Troponin Subunit
510(k) Number K172783
Device Name Access hs Tnl
Applicant
Beckman Coulter, Inc.
1000 Lake Hazeltine Drive MS R-540-C
Immunodiagnostic Development Center
Chaska,  MN  55318 -1084
Applicant Contact Kerrie Sue Oetter
Correspondent
Beckman Coulter, Inc.
1000 Lake Hazeltine Drive
Chaska,  MN  55318 -1084
Correspondent Contact Kerrie Sue Oetter
Regulation Number862.1215
Classification Product Code
MMI  
Date Received09/15/2017
Decision Date 06/12/2018
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
Recalls CDRH Recalls
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