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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K971405
Device Name SPECIALITY URINE 1,2
Applicant
Chiron Diagnostics Corp.
17392 Daimler St.
Irvine,  CA  92614
Applicant Contact RONALD D SCHAEFER
Correspondent
Chiron Diagnostics Corp.
17392 Daimler St.
Irvine,  CA  92614
Correspondent Contact RONALD D SCHAEFER
Regulation Number862.1660
Classification Product Code
JJY  
Date Received04/16/1997
Decision Date 06/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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