MICROSCAN MICROSTEP


Device Classification Name

panels, test, susceptibility, antimicrobial

510(k) Number K111394
Device Name MICROSCAN MICROSTEP
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
LTT  
Subsequent Product Codes
JWY   LRG   LTW  
Date Received 05/18/2011
Decision Date 06/22/2011
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