CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K110061
Device Name CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
tarrytown, 
NY 
10591 -5097

Applicant Contact ernest joseph
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
tarrytown, 
NY 
10591 -5097

Correspodent Contact ernest joseph
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 01/10/2011
Decision Date 09/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No

Combination Product

No