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 Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
510(k) Number K180559
Device Name HSV 1 & 2 ELITe MGB Kit; ELITe InGenius
Applicant
Elitechgroup
21720 23rd Dr. SE Suite 150
Bothell,  WA  98021
Applicant Contact Terry Trimingham
Correspondent
Elitechgroup
21720 23rd Dr. SE Suite 150
Bothell,  WA  98021
Correspondent Contact Walt Mahoney
Regulation Number866.3309
Classification Product Code
PGI  
Subsequent Product Code
OOI  
Date Received03/01/2018
Decision Date 10/29/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-