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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 K871687
Device Name TYTEM(R) REAGENT DISPENSER
Applicant
Medical Laboratory Automation Systems, Inc.
270 Marble Ave.
Pleasantville,  NY  10570
Applicant Contact JOANN HANCHROW
Correspondent
Medical Laboratory Automation Systems, Inc.
270 Marble Ave.
Pleasantville,  NY  10570
Correspondent Contact JOANN HANCHROW
Regulation Number862.2750
Classification Product Code
JQW  
Date Received04/29/1987
Decision Date 05/20/1987
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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