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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Blood Collection
510(k) Number K780303
Device Name AUTO ISO-FILTER COLLECTION TUBE CAP
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 Number862.1675
Classification Product Code
GJE  
Date Received02/23/1978
Decision Date 03/30/1978
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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