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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Blood Culturing
510(k) Number K000378
Device Name BACT/ALERT MB CULTURE BOTTLE
Applicant
ORGANON TEKNIKA CORP.
100 AKZO AVE.
DURHAM,  NC  27712
Applicant Contact REBECCA A RIVAS
Correspondent
ORGANON TEKNIKA CORP.
100 AKZO AVE.
DURHAM,  NC  27712
Correspondent Contact REBECCA A RIVAS
Regulation Number866.2560
Classification Product Code
MDB  
Date Received02/07/2000
Decision Date 03/02/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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