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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Enzyme, For Clinical Use
510(k) Number K770401
Device Name LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE
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 Number862.2500
Classification Product Code
JJI  
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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