MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN (0.004-16UG/ML)


Device Classification Name

system, test, automated, antimicrobial susceptibility, short incubation

510(k) Number K023541
Device Name MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN (0.004-16UG/ML)
Original Applicant
DADE BEHRING, INC.
1584 enterprise blvd.
west sacramento, 
CA 
95691

Original Contact cynthia van duker
Regulation Number 866.1645
Classification Product Code
LON  
Date Received 10/22/2002
Decision Date 12/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No