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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catalytic Methods, Amylase
510(k) Number K800049
Device Name DELTA TEST AMYLASE UV
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
JFJ  
Date Received01/09/1980
Decision Date 01/23/1980
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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