AMMONIA ASSAY FOR THE ADVIA 1650


Device Classification Name

enzymatic method, ammonia

510(k) Number K023841
Device Name AMMONIA ASSAY FOR THE ADVIA 1650
Original Applicant
BAYER DIAGNOSTICS CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

Original Contact andres holle
Regulation Number 862.1065
Classification Product Code
JIF  
Subsequent Product Code
JIT  
Date Received 11/18/2002
Decision Date 12/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No