MICROSCAN (R) MICROSTREP PLUS (R) PANELS


Device Classification Name

instrument for auto reader & interpretation of overnight suscept. systems

510(k) Number K111205
Device Name MICROSCAN (R) MICROSTREP PLUS (R) PANELS
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
1584 enterprise blvd.
west sacramento, 
CA 
95691

Applicant Contact shannon popson
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
1584 enterprise blvd.
west sacramento, 
CA 
95691

Correspodent Contact shannon popson
Regulation Number 866.1640
Classification Product Code
LRG  
Subsequent Product Codes
JWY   LTW  
Date Received 04/29/2011
Decision Date 07/20/2011
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