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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 K953345
Device Name GENESIS
Applicant
Tecan U.S., Inc.
P.O. Box 13953
Research Triangle Park,  NC  27709
Applicant Contact DAVID L JURANAS
Correspondent
Tecan U.S., Inc.
P.O. Box 13953
Research Triangle Park,  NC  27709
Correspondent Contact DAVID L JURANAS
Regulation Number862.2750
Classification Product Code
JQW  
Date Received07/12/1995
Decision Date 11/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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