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 hemoglobin a1c test system
510(k) Number K173909
Device Name Dimension Hemoglobin A1c Assay
Applicant
Siemens Healthcare Diagnostics Inc.
P.O. Box 6101
M/S 514
Newark,  DE  19714 -6101
Applicant Contact Alan Haley
Correspondent
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE
Newark,  DE  19702
Correspondent Contact Alan Haley
Regulation Number862.1373
Classification Product Code
PDJ  
Subsequent Product Code
LCP  
Date Received12/22/2017
Decision Date 07/13/2018
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
-
-