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 Lipoprotein, Low-Density, Antigen, Antiserum, Control
510(k) Number K050487
Device Name QUANTIA LA(A)
Applicant
Biokit, S.A.
Can Male Llissa D'Amunt
Barcelona,  ES 08186
Applicant Contact JOAN GUIXER
Correspondent
Biokit, S.A.
Can Male Llissa D'Amunt
Barcelona,  ES 08186
Correspondent Contact JOAN GUIXER
Regulation Number866.5600
Classification Product Code
DFC  
Subsequent Product Codes
JIS   JJX  
Date Received02/25/2005
Decision Date 04/26/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-