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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 K992400
Device Name BACTALERT FA
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 Received07/19/1999
Decision Date 09/03/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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