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 Immunoabsorbent Assay, Rubella
510(k) Number K092587
Device Name BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM
Applicant
Bio-Rad Laboratories
5500 E. Second St.
Benicia,  CA  94510
Applicant Contact Patricia Klimley
Correspondent
Bio-Rad Laboratories
5500 E. Second St.
Benicia,  CA  94510
Correspondent Contact Patricia Klimley
Regulation Number866.3510
Classification Product Code
LFX  
Subsequent Product Codes
JIX   JJX   LFZ   LKQ  
Date Received08/24/2009
Decision Date 12/03/2010
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
-
-