IMMULITE 2500 OM-MA, MODEL L5KOP


Device Classification Name

test, epithelial ovarian tumor-associated antigen (ca125)

510(k) Number K072794
Device Name IMMULITE 2500 OM-MA, MODEL L5KOP
Applicant
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
5210 pacific concourse dr.
los angeles, 
CA 
90045 -6900

Applicant Contact maya mahue-giangreco
Correspondent
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
5210 pacific concourse dr.
los angeles, 
CA 
90045 -6900

Correspodent Contact maya mahue-giangreco
Regulation Number 866.6010
Classification Product Code
LTK  
Subsequent Product Code
JJY  
Date Received 10/01/2007
Decision Date 11/05/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No