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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 K981736
Device Name BACT/ALERT 3D MICROBIAL DETECTION SYSTEM
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 Received05/18/1998
Decision Date 07/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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