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, Elisa, Cryptococcus
510(k) Number K120946
Device Name ALPHA CRYPTOCOCCAL ANTIGEN EIA
Applicant
Immuno-Mycologics, Inc.
116 S Crawford Ave.
Norman,  OK  73069
Applicant Contact SEAN K BAUMAN
Correspondent
Immuno-Mycologics, Inc.
116 S Crawford Ave.
Norman,  OK  73069
Correspondent Contact SEAN K BAUMAN
Regulation Number866.3165
Classification Product Code
MDU  
Date Received03/29/2012
Decision Date 12/17/2012
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
-
-