DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE


Device Classification Name

assay, porphyrin, spectrophotometry, lithium

510(k) Number K112142
Device Name DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
p.o. box 6101
newark, 
DE 
19714 -6101

Applicant Contact rose t marinelli
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
p.o. box 6101
newark, 
DE 
19714 -6101

Correspodent Contact rose t marinelli
Regulation Number 862.3560
Classification Product Code
NDW  
Subsequent Product Code
JIX  
Date Received 07/26/2011
Decision Date 11/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls