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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 K854406
Device Name TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500
Applicant
Tecan U.S., Ltd.
P.O. Box 8101
Hillsborough,  NC  27278
Applicant Contact WERNER MARTIN
Correspondent
Tecan U.S., Ltd.
P.O. Box 8101
Hillsborough,  NC  27278
Correspondent Contact WERNER MARTIN
Regulation Number862.2750
Classification Product Code
JQW  
Date Received11/01/1985
Decision Date 02/10/1986
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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