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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K770731
Device Name EAGENT SYSTEM, CORTISOL, ARIA
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
Date Received04/20/1977
Decision Date 06/24/1977
Decision Substantially Equivalent (SESE)
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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