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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K884378
Device Name DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER
Applicant
Coulter Corp.
745 W. 83rd St.
Hialeah,  FL  33014
Applicant Contact RICHARDSON-JONES
Correspondent
Coulter Corp.
745 W. 83rd St.
Hialeah,  FL  33014
Correspondent Contact RICHARDSON-JONES
Regulation Number862.2160
Classification Product Code
JJE  
Date Received10/18/1988
Decision Date 02/27/1989
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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