TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS


Device Classification Name

enzyme linked immunoabsorption assay, treponema pallidum

510(k) Number K112343
Device Name TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 benedict ave
tarrytown, 
NY 
10591

Applicant Contact kira gordon
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 benedict ave
tarrytown, 
NY 
10591

Correspodent Contact kira gordon
Regulation Number 866.3830
Classification Product Code
LIP  
Date Received 08/15/2011
Decision Date 01/20/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls