• 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 system, hemoglobin, automated
510(k) Number K122553
Device Name MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM
Original Applicant
ACON LABORATORIES, INC.
10125 mesa rim road
san diego,  CA  92121
Original Contact qiyi xie
Regulation Number864.5620
Classification Product Code
GKR  
Subsequent Product Code
JJX  
Date Received08/21/2012
Decision Date 08/05/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-