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 Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
510(k) Number K120439
Device Name BIOPLEX 2200 EBV IGG AND SYPHILIS IGG
Applicant
Bio-Rad Laboratories, Inc.
5500 E. 2nd St.
Benicia,  CA  94510
Applicant Contact Juang Wang
Correspondent
Bio-Rad Laboratories, Inc.
5500 E. 2nd St.
Benicia,  CA  94510
Correspondent Contact Juang Wang
Regulation Number866.3830
Classification Product Code
LIP  
Subsequent Product Codes
JIX   JJY   LSE  
Date Received02/13/2012
Decision Date 03/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-