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 Radioimmunoassay, Vancomycin
510(k) Number K123947
Device Name ARCHITECT IVANCOMYCIN
Applicant
Biokit, S.A.
Can Male, S/N
Llissa D'Amunt, Barcelona,  ES 08186
Applicant Contact GUILLEM ANGLERILL
Correspondent
Biokit, S.A.
Can Male, S/N
Llissa D'Amunt, Barcelona,  ES 08186
Correspondent Contact GUILLEM ANGLERILL
Regulation Number862.3950
Classification Product Code
LEH  
Date Received12/21/2012
Decision Date 08/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-