CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM


Device Classification Name

system, test, immunological, antigen, tumor

510(k) Number K022178
Device Name CA 15-3 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 866.6010
Classification Product Code
MOI  
Subsequent Product Code
JIT  
Date Received 07/03/2002
Decision Date 11/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No