LIASYS WITH MODELS LIASYS


Device Classification Name

hexokinase, glucose

510(k) Number K080468
Device Name LIASYS WITH MODELS LIASYS
Applicant
AMS S.R.L. ANALYZER MEDICAL SYSTEM
17/a via e. barsanti
guidonia (rome), 

IT

i-00012

Applicant Contact stefano corradi
Correspondent
AMS S.R.L. ANALYZER MEDICAL SYSTEM
17/a via e. barsanti
guidonia (rome), 

IT

i-00012

Correspodent Contact stefano corradi
Regulation Number 862.1345
Classification Product Code
CFR  
Subsequent Product Codes
CDN   CEM   CGX   CGZ   CIT  
JGS   JJE  
Date Received 02/21/2008
Decision Date 07/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No