BD MAX GBS ASSAY, BD MAX INSTRUMENT


Device Classification Name

nucleic acid amplification assay system, group b streptococcus, direct specimen test

510(k) Number K111860
Device Name BD MAX GBS ASSAY, BD MAX INSTRUMENT
Applicant
BECTON DICKINSON & CO.
7 loveton cir.
baltimore, 
MD 
21152

Applicant Contact mary anne williams
Correspondent
BECTON DICKINSON & CO.
7 loveton cir.
baltimore, 
MD 
21152

Correspodent Contact mary anne williams
Regulation Number 866.3740
Classification Product Code
NJR  
Subsequent Product Code
OOI  
Date Received 06/30/2011
Decision Date 02/16/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls