• 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 rt-qpcr assay for mrna transcript immune biomarkers
510(k) Number K203748
Device Name SeptiCyte RAPID
Applicant
Immunexpress, Inc
425 Pontius Avenue North, Suite 470
Seattle,  WA  98109
Applicant Contact LaKesha Hunt-Dickens
Correspondent
Immunexpress, Inc
425 Pontius Avenue North, Suite 470
Seattle,  WA  98109
Correspondent Contact LaKesha Hunt-Dickens
Regulation Number866.3215
Classification Product Code
PRE  
Date Received12/23/2020
Decision Date 11/29/2021
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
-
-