MICROSCAN(R) MICROSTREP PLUS(R)


Device Classification Name

instrument for auto reader & interpretation of overnight suscept. systems

510(k) Number K111677
Device Name MICROSCAN(R) MICROSTREP PLUS(R)
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
1584 enterprise blvd.
west sacramento, 
CA 
95691

Applicant Contact jenifer dawson driscoll
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
1584 enterprise blvd.
west sacramento, 
CA 
95691

Correspodent Contact jenifer dawson driscoll
Regulation Number 866.1640
Classification Product Code
LRG  
Subsequent Product Codes
JWY   LTW  
Date Received 06/15/2011
Decision Date 08/04/2011
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