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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, Centrifugal, For Clinical Use
510(k) Number K790550
Device Name CENTRIA SYSTEM
Applicant
Union Carbide Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Union Carbide Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2140
Classification Product Code
JJG  
Date Received03/20/1979
Decision Date 05/07/1979
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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