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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microtitrator, For Clinical Use
510(k) Number K963268
Device Name GENESIS RMP
Applicant
Tecan U.S., Inc.
P.O. Box 13953
Research Triangle Park,  NC  27709
Applicant Contact CHRISTY LYCAN
Correspondent
Tecan U.S., Inc.
P.O. Box 13953
Research Triangle Park,  NC  27709
Correspondent Contact CHRISTY LYCAN
Regulation Number862.2680
Classification Product Code
JRA  
Date Received08/20/1996
Decision Date 03/18/1997
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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