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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 K121214
FOIA Releasable 510(k) K121214
Device Name ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
Applicant
Beckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact KERRIE OETTER
Correspondent
Beckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact KERRIE OETTER
Regulation Number862.1215
Classification Product Code
MMI  
Subsequent Product Codes
JIT   JJE  
Date Received04/23/2012
Decision Date 06/14/2013
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
Recalls CDRH Recalls
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