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 Fluorometric Method, Cpk Or Isoenzymes
510(k) Number K120326
Device Name AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE
Applicant
Radiometer Medical Aps
Akandevej 21 Dk-2700
Bronshoj,  DK
Applicant Contact OLE SCHOU
Correspondent
Radiometer Medical Aps
Akandevej 21 Dk-2700
Bronshoj,  DK
Correspondent Contact OLE SCHOU
Regulation Number862.1215
Classification Product Code
JHX  
Subsequent Product Codes
JIT   JJY  
Date Received02/02/2012
Decision Date 11/21/2012
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
Predetermined Change
Control Plan Authorized		 No
-
-