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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K893835
Device Name DAU I, DAU II, DAU III AND DAU IV CONTROL URINE
Applicant
Ciba Corning Diagnostics Corp.
333 Coney St.
East Walpole,  MA  02032
Applicant Contact D SCHAEFER
Correspondent
Ciba Corning Diagnostics Corp.
333 Coney St.
East Walpole,  MA  02032
Correspondent Contact D SCHAEFER
Regulation Number862.3280
Classification Product Code
DIF  
Date Received05/24/1989
Decision Date 07/25/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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