Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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, immunological, antigen, tumor
510(k) Number K100344
Device Name DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
MS 514, PO BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact ROSE MARINELLI
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
MS 514, PO BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact ROSE MARINELLI
Regulation Number866.6010
Classification Product Code
MOI  
Subsequent Product Code
JIX  
Date Received02/05/2010
Decision Date 04/18/2011
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
Recalls CDRH Recalls
-
-