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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 K970616
Device Name MINI SAMPLER PROCESSOR
Applicant
Cavro Scientific Instruments, Inc.
242 Humboldt Ct.
Sunnyvale,  CA  94089
Applicant Contact FRED WOLCOTT
Correspondent
Cavro Scientific Instruments, Inc.
242 Humboldt Ct.
Sunnyvale,  CA  94089
Correspondent Contact FRED WOLCOTT
Regulation Number862.2750
Classification Product Code
JQW  
Date Received02/18/1997
Decision Date 04/21/1997
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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