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 Epstein-Barr Virus, Other
510(k) Number K912488
Device Name FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS
Applicant
Immuno Concepts, Inc.
9779-D Business Park Dr.
Sacramento,  CA  95827
Applicant Contact ERIC S HOY
Correspondent
Immuno Concepts, Inc.
9779-D Business Park Dr.
Sacramento,  CA  95827
Correspondent Contact ERIC S HOY
Regulation Number866.3235
Classification Product Code
LSE  
Date Received06/04/1991
Decision Date 07/24/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-