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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 K973335
Device Name QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)
Applicant
Zenyx Scientific , Ltd.
Barnes Hospital
Cheadle, Cheshire,  GB SKB 2NY
Applicant Contact PAUL W MCWALTER
Correspondent
Zenyx Scientific , Ltd.
Barnes Hospital
Cheadle, Cheshire,  GB SKB 2NY
Correspondent Contact PAUL W MCWALTER
Regulation Number862.2750
Classification Product Code
JQW  
Date Received09/04/1997
Decision Date 04/30/1998
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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