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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Folic, Radioimmunoassay
510(k) Number K060774
Device Name FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208
Applicant
Beckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318 -1084
Applicant Contact CAROLYN ANDERSON
Correspondent
Beckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318 -1084
Correspondent Contact CAROLYN ANDERSON
Regulation Number862.1295
Classification Product Code
CGN  
Date Received03/22/2006
Decision Date 04/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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