• 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 | 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 controls for blood-gases, (assayed and unassayed)
510(k) Number K130415
Device Name HIGH METABOLITE QUALICHECK
Original Applicant
RADIOMETER MEDICAL APS
aakandevej 21
broenshoej,  DK dk-2700
Original Contact martin gabler
Regulation Number862.1660
Classification Product Code
JJS  
Date Received02/19/2013
Decision Date 03/26/2013
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
-
-