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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Column Chromatography & Color Development, Hydroxyproline
510(k) Number K963251
Device Name CIBA CORNING ACS;180 DPD ASSAY
Applicant
Ciba Corning Diagnostics Corp.
17392 Daimler St.
Irvine,  CA  92714
Applicant Contact William J Pignato
Correspondent
Ciba Corning Diagnostics Corp.
17392 Daimler St.
Irvine,  CA  92714
Correspondent Contact William J Pignato
Regulation Number862.1400
Classification Product Code
JMM  
Date Received08/19/1996
Decision Date 10/15/1996
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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