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 Reagent, Borrelia Serological Reagent
510(k) Number K080012
Device Name PLATELIA LYME IGG ASSAY
Applicant
Bio-Rad
163 Cabot St.
Beverly,  MA  01915
Applicant Contact FRAN WHITE
Correspondent
Bio-Rad
163 Cabot St.
Beverly,  MA  01915
Correspondent Contact FRAN WHITE
Regulation Number866.3830
Classification Product Code
LSR  
Date Received01/03/2008
Decision Date 05/08/2008
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
-
-