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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K141388
Device Name SYSTEM CALIBRATER
Applicant
Beckman Coulter Ireland, Inc.
250 S. Kraemer Blvd. E1. Se. 01
Brea,  CA  92821
Applicant Contact DAVID G DAVIS
Correspondent
Beckman Coulter Ireland, Inc.
250 S. Kraemer Blvd. E1. Se. 01
Brea,  CA  92821
Correspondent Contact DAVID G DAVIS
Regulation Number862.1150
Classification Product Code
JIX  
Date Received05/27/2014
Decision Date 07/11/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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