MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN


Device Classification Name

instrument for auto reader & interpretation of overnight suscept. systems

510(k) Number K081013
Device Name MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
2040 enterprise blvd.
west sacramento, 
CA 
95691

Applicant Contact libby warriner
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
2040 enterprise blvd.
west sacramento, 
CA 
95691

Correspodent Contact libby warriner
Regulation Number 866.1640
Classification Product Code
LRG  
Subsequent Product Codes
JWY   LTT   LTW  
Date Received 04/09/2008
Decision Date 09/08/2008
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