BACTALERT FA


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

Correspodent Contact rebecca a rivas
Regulation Number 866.2560
Classification Product Code
MDB  
Date Received 07/19/1999
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