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 c-reactive protein, antigen, antiserum, and control
510(k) Number K141689
Device Name FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit
Applicant
Qualigen, Inc.
2042 CORTE DEL NOGAL
CARLSBAD,  CA  92011
Applicant Contact Michael Poirier
Correspondent
Qualigen, Inc.
2042 CORTE DEL NOGAL
CARLSBAD,  CA  92011
Correspondent Contact Michael Poirier
Regulation Number866.5270
Classification Product Code
DCK  
Subsequent Product Codes
JIT   JJX  
Date Received06/23/2014
Decision Date 01/07/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-