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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic, Carbon-Dioxide
510(k) Number K131546
Device Name AU BICARBONATE REAGENT
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 Number862.1160
Classification Product Code
KHS  
Date Received05/29/2013
Decision Date 10/09/2013
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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