MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST – INDUCIBLE CLINDAMYCIN


Device Classification Name

manual antimicrobial susceptibility test systems

510(k) Number K081182
Device Name MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST – INDUCIBLE CLINDAMYCIN
Applicant
SIEMENS
1584 enterprise blvd.
west sacramento, 
CA 
95691

Applicant Contact libby warriner
Correspondent
SIEMENS
1584 enterprise blvd.
west sacramento, 
CA 
95691

Correspodent Contact libby warriner
Regulation Number 866.1640
Classification Product Code
JWY  
Subsequent Product Codes
LRG   LTT   LTW  
Date Received 04/25/2008
Decision Date 08/08/2008
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