BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)


Device Classification Name

nadh oxidation/nad reduction, ast/sgot

510(k) Number K992136
Device Name BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)
Applicant
BAYER CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

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

Correspodent Contact gabriel j muraca
Regulation Number 862.1100
Classification Product Code
CIT  
Subsequent Product Codes
CGX   DLZ   JLB  
Date Received 06/24/1999
Decision Date 11/09/1999
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