VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID


Device Classification Name

system, test, automated, antimicrobial susceptibility, short incubation

510(k) Number K022045
Device Name VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID
Original Applicant
BIOMERIEUX, INC.
595 anglum rd.
hazelwood, 
MO 
63042

Original Contact nancy weaver
Regulation Number 866.1645
Classification Product Code
LON  
Date Received 06/24/2002
Decision Date 08/15/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

Type Traditional
Reviewed by Third Party No

Combination Product

No