• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name system, test, radioallergosorbent (rast) immunological
510(k) Number K083314
Device Name IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict Avenue
tarrytown,  NY  10591
Applicant Contact clare santulli
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict Avenue
tarrytown,  NY  10591
Correspondent Contact clare santulli
Regulation Number866.5750
Classification Product Code
DHB  
Date Received11/10/2008
Decision Date 03/11/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-