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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controls For Blood-Gases, (Assayed And Unassayed)
510(k) Number K946224
Device Name CERTAIN(R) ELITE LEVEL 1, 2 AND 3
Applicant
Ciba Corning Diagnostics Corp.
333 Coney St.
East Walpole,  MA  02032
Applicant Contact STEVEN R RAKITIN
Correspondent
Ciba Corning Diagnostics Corp.
333 Coney St.
East Walpole,  MA  02032
Correspondent Contact STEVEN R RAKITIN
Regulation Number862.1660
Classification Product Code
JJS  
Date Received11/14/1994
Decision Date 01/30/1995
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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