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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 K912036
Device Name ROBOTIC SAMPLE PROCESSOR
Applicant
Tecan U.S., Ltd.
164 Dimmocks Mill Rd.
P.O. Box 8101
Hillsborough,  NC  27278
Applicant Contact DAVID L JURANAS
Correspondent
Tecan U.S., Ltd.
164 Dimmocks Mill Rd.
P.O. Box 8101
Hillsborough,  NC  27278
Correspondent Contact DAVID L JURANAS
Regulation Number862.2750
Classification Product Code
JQW  
Date Received05/08/1991
Decision Date 07/26/1991
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
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