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 radioimmunoassay, testosterones and dihydrotestosterone
510(k) Number K101388
Device Name FASTPACK TESTO IMMUNOASSAY
Applicant
Qualigen, Inc.
2042 CORTE DEL NOGAL
SUITE B
CARLSBAD,  CA  92011 -1438
Applicant Contact MICHAEL S POIRIER
Correspondent
Qualigen, Inc.
2042 CORTE DEL NOGAL
SUITE B
CARLSBAD,  CA  92011 -1438
Correspondent Contact MICHAEL S POIRIER
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received05/17/2010
Decision Date 02/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-