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 System, Test, Infectious Mononucleosis
510(k) Number K042272
Device Name ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
Applicant
ACON Laboratories, Inc.
4108 Sorrento Valley Blvd.
San Diego,  CA  92121
Applicant Contact EDWARD TUNG, PH.D.
Correspondent
ACON Laboratories, Inc.
4108 Sorrento Valley Blvd.
San Diego,  CA  92121
Correspondent Contact EDWARD TUNG, PH.D.
Regulation Number866.5640
Classification Product Code
KTN  
Date Received08/23/2004
Decision Date 02/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-