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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 K885340
Device Name AIR DISPLACEMENT PIPETTE
Applicant
Ulster Scientific, Inc.
P.O. Box 902
Highland,  NY  12528
Applicant Contact ROBERT K MCEWEN
Correspondent
Ulster Scientific, Inc.
P.O. Box 902
Highland,  NY  12528
Correspondent Contact ROBERT K MCEWEN
Regulation Number862.2750
Classification Product Code
JQW  
Date Received12/28/1988
Decision Date 02/14/1989
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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