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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 K942655
Device Name 4 CHANNEL DISPENSER
Applicant
Tecan U.S., Inc.
P.O. Box 13953
Research Triangle Park,  NC  27709
Applicant Contact DANIEL B ROARK
Correspondent
Tecan U.S., Inc.
P.O. Box 13953
Research Triangle Park,  NC  27709
Correspondent Contact DANIEL B ROARK
Regulation Number862.2750
Classification Product Code
JQW  
Date Received06/06/1994
Decision Date 09/02/1994
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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