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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, Micro, For Clinical Use
510(k) Number K961209
Device Name BRIO AUTOMATIC SAMPLINC UNIT
Applicant
Seac S.R.L.
45 Pontial Ro
Newton,  MA  02168
Applicant Contact JOSEPH RESS
Correspondent
Seac S.R.L.
45 Pontial Ro
Newton,  MA  02168
Correspondent Contact JOSEPH RESS
Regulation Number862.2170
Classification Product Code
JJF  
Date Received03/28/1996
Decision Date 12/24/1996
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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