IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K103683
Device Name IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
tarrytown, 
NY 
10591

Applicant Contact garo mimaryan
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
tarrytown, 
NY 
10591

Correspodent Contact garo mimaryan
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 12/17/2010
Decision Date 04/28/2011
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