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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name assay, glycosylated hemoglobin
510(K) Number K121366
Device Name HEMOCUE HBA1C 501
Applicant
INFOPIA CO., LTD
55 northern blvd.
suite 200
great neck,  NY  11021
Contact maria f griffin
Regulation Number864.7470
Classification Product Code
LCP  
Date Received05/07/2012
Decision Date 09/07/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Hematology
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-