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 assay, glycosylated hemoglobin
510(k) Number K041635
Device Name G5 I HBA1C TEST, G5 II HBA1C TEST
Applicant
PROVALIS DIAGNOSTICS LTD.
16809 BRIARDALE RD.
ROCKVILLE,  MD  20855
Applicant Contact THOMAS M TSAKERIS
Correspondent
PROVALIS DIAGNOSTICS LTD.
16809 BRIARDALE RD.
ROCKVILLE,  MD  20855
Correspondent Contact THOMAS M TSAKERIS
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
GGM  
Date Received06/16/2004
Decision Date 08/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-