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 Calibrator, Secondary
510(k) Number K022533
Device Name FASTPACK TESTOSTERONE CALIBRATOR
Applicant
Qualigen, Inc.
2042 Corte Del Nogal
Carlsbad,  CA  92009
Applicant Contact DOROTHY DEINZER
Correspondent
Qualigen, Inc.
2042 Corte Del Nogal
Carlsbad,  CA  92009
Correspondent Contact DOROTHY DEINZER
Regulation Number862.1150
Classification Product Code
JIT  
Date Received07/31/2002
Decision Date 09/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-