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 Antigen, Galactomannan, Aspergillus Spp.
510(k) Number K093678
Device Name PLATELIA ASPERGILLUS EIA MODEL 62793
Applicant
Bio-Rad
6565 185th Ave., NE
Redmond,  WA  98052
Applicant Contact CHRISTOPHER BENTSEN
Correspondent
Bio-Rad
6565 185th Ave., NE
Redmond,  WA  98052
Correspondent Contact CHRISTOPHER BENTSEN
Regulation Number866.3040
Classification Product Code
NOM  
Date Received11/27/2009
Decision Date 01/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-