ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM


Device Classification Name

saccharogenic, amylase

510(k) Number K991817
Device Name ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
Applicant
BAYER CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

Applicant Contact gabriel j muraca jr.
Correspondent
BAYER CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

Correspodent Contact gabriel j muraca jr.
Regulation Number 862.1070
Classification Product Code
CIJ  
Date Received 05/27/1999
Decision Date 07/22/1999
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