ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM


the company

Device Classification Name

enzyme immunoassay, carbamazepine

510(k) Number K000903
Device Name ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM
Original Applicant
BAYER CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

Original Contact fredrick clerie
Regulation Number 862.3645
Classification Product Code
KLT  
Subsequent Product Code
LBZ  
Date Received 03/21/2000
Decision Date 05/18/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No