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 Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
510(k) Number K120959
Device Name BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT
Applicant
Bio-Rad Laboratories
Bioplex 2200 Division
5500 E. Second St.
Benicia,  CA  94510
Applicant Contact Juang Wang
Correspondent
Bio-Rad Laboratories
Bioplex 2200 Division
5500 E. Second St.
Benicia,  CA  94510
Correspondent Contact Juang Wang
Regulation Number866.3305
Classification Product Code
MXJ  
Subsequent Product Codes
JIX   JJY   MYF  
Date Received03/30/2012
Decision Date 06/22/2012
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
-
-