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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Station, Pipetting And Diluting, For Clinical Use
510(k) Number K962687
Device Name GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM
Applicant
Nichols Institute Diagnostics
33608 Ortega Hwy.
San Juan Capistrano,  CA  92690
Applicant Contact DAVE D SMITH
Correspondent
Nichols Institute Diagnostics
33608 Ortega Hwy.
San Juan Capistrano,  CA  92690
Correspondent Contact DAVE D SMITH
Regulation Number862.2750
Classification Product Code
JQW  
Date Received07/11/1996
Decision Date 03/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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