BACTEC MGIT 960 PZA KIT


Device Classification Name

susceptibility test powders, antimycobacterial

510(k) Number K021582
Device Name BACTEC MGIT 960 PZA KIT
Original Applicant
BECTON, DICKINSON & CO.
7 loveton cir.
sparks, 
MD 
21152 -0999

Original Contact michelle b bandy
Regulation Number 866.1640
Classification Product Code
MJA  
Date Received 05/14/2002
Decision Date 07/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No