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 Dna Specimen Collection, Saliva
510(k) Number K212745
Device Name ORAcollect®•Dx
Applicant
DNA Genotek, Inc.
3000 - 500 Palladium Dr.
Ottawa,  CA K2V 1C2
Applicant Contact Austin Udocor
Correspondent
DNA Genotek, Inc.
3000 - 500 Palladium Dr.
Ottawa,  CA K2V 1C2
Correspondent Contact Jonathan Chan
Regulation Number862.1675
Classification Product Code
OYJ  
Date Received08/30/2021
Decision Date 10/27/2022
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
-
-