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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 K883055
Device Name DART CARBON DIOXIDE
Applicant
Coulter Electronics, Inc.
745 W. 83rd St.
Hialeah,  FL  33014
Applicant Contact RICHARDSON-JONES
Correspondent
Coulter Electronics, Inc.
745 W. 83rd St.
Hialeah,  FL  33014
Correspondent Contact RICHARDSON-JONES
Regulation Number862.1160
Classification Product Code
KHS  
Date Received07/19/1988
Decision Date 08/30/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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