ADVIA IMS LITHIUM ASSAY


Device Classification Name

assay, porphyrin, spectrophotometry, lithium

510(k) Number K050374
Device Name ADVIA IMS LITHIUM ASSAY
Applicant
BAYER HEALTHCARE, LLC
511 benedict ave.
tarrytown, 
NY 
10591

Applicant Contact andres holle
Correspondent
BAYER HEALTHCARE, LLC
511 benedict ave.
tarrytown, 
NY 
10591

Correspodent Contact andres holle
Regulation Number 862.3560
Classification Product Code
NDW  
Subsequent Product Codes
JIX   JJY  
Date Received 02/14/2005
Decision Date 06/15/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls