BAYER LIGAND PLUS 1, 2, 3 CONTROLS


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K030452
Device Name BAYER LIGAND PLUS 1, 2, 3 CONTROLS
Applicant
BAYER DIAGNOSTICS CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

Applicant Contact kenneth t edds
Correspondent
BAYER DIAGNOSTICS CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

Correspodent Contact kenneth t edds
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 02/11/2003
Decision Date 03/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No