IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K122534
Device Name IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL
Applicant
Siemens Healthcare Diagnostics Inc.
511 benedict ave.
tarrytown, 
NY 
10591

Applicant Contact garo mimaryan
Correspondent
Siemens Healthcare Diagnostics Inc.
511 benedict ave.
tarrytown, 
NY 
10591

Correspodent Contact garo mimaryan
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 08/20/2012
Decision Date 03/14/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No

Combination Product

No