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 Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K983914
Device Name REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT
Applicant
Corgenix, Inc.
12061 Tejon St.
Westminster,  CO  80234
Applicant Contact NANCI DEXTER
Correspondent
Corgenix, Inc.
12061 Tejon St.
Westminster,  CO  80234
Correspondent Contact NANCI DEXTER
Regulation Number864.7290
Classification Product Code
GGP  
Date Received11/04/1998
Decision Date 12/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-