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 Jak2 Gene Mutation Detection Test
510(k) Number K172287
Device Name ipsogen JAK2 RGQ PCR Kit
Applicant
QIAGEN, Inc.
19300 Germantown Road
Germantown,  MD  20874
Applicant Contact Lindsey Howard
Correspondent
QIAGEN Manchester, Ltd.
Skelton House, Lloyd Street North
Manchester,  GB M15 6SH
Correspondent Contact Claire Ryan
Classification Product Code
PSU  
Date Received07/28/2017
Decision Date 01/12/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Molecular Genetics
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-