• 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 | Inspections
 


New Search Back To Search Results
Device Classification Name analyzer, chemistry (photometric, discrete), for clinical use
510(k) Number K130276
Device Name DIMENSION EXL WITH LM SYSTEM
Original Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
500 gbc drive m/s 514
p.o. box 6101
newark,  DE  19714 -3026
Original Contact pamela a jurga
Regulation Number862.2160
Classification Product Code
JJE  
Subsequent Product Code
CEC  
Date Received02/05/2013
Decision Date 03/22/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-