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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K910740
Device Name SLT MICROPLATE WASHER
Applicant
Tecan U.S., Ltd.
164 Dimmocks Mill Rd.
P.O. Box 8101
Hillsborough,  NC  27278
Applicant Contact DANIEL B ROARK
Correspondent
Tecan U.S., Ltd.
164 Dimmocks Mill Rd.
P.O. Box 8101
Hillsborough,  NC  27278
Correspondent Contact DANIEL B ROARK
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received02/21/1991
Decision Date 03/27/1991
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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