MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN

Device Classification Name

instrument for auto reader & interpretation of overnight suscept. systems

510(k) Number K071316
Device Name MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN
Applicant
DADE BEHRING, INC.
2040 enterprise blvd.
west sacramento, 
CA 
95691

Applicant Contact robert eusebio
Correspondent
DADE BEHRING, INC.
2040 enterprise blvd.
west sacramento, 
CA 
95691

Correspodent Contact robert eusebio
Regulation Number 866.1640
Classification Product Code
LRG  
Subsequent Product Codes
JWY   LTT  
Date Received 05/10/2007
Decision Date 08/20/2007
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