AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM


Device Classification Name

enzymatic method, ammonia

510(k) Number K021151
Device Name AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
Original Applicant
BAYER DIAGNOSTICS CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

Original Contact kenneth t edds
Regulation Number 862.1065
Classification Product Code
JIF  
Date Received 04/10/2002
Decision Date 07/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No