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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Gentamicin
510(k) Number K953020
Device Name ACS GENTAMICIN
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 Number862.3450
Classification Product Code
LCD  
Date Received06/29/1995
Decision Date 08/02/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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