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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nephelometric, Amylase
510(k) Number K770400
Device Name REAGENT, AMYLASE LIPASE
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Regulation Number862.1070
Classification Product Code
KHM  
Date Received03/02/1977
Decision Date 04/26/1977
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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