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 Complement C3, Antigen, Antiserum, Control
510(k) Number K871346
Device Name DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY
Applicant
Dako Corp.
22 N. Milpas St.
Santa Barbara,  CA  93103
Applicant Contact BROOKS, PHD
Correspondent
Dako Corp.
22 N. Milpas St.
Santa Barbara,  CA  93103
Correspondent Contact BROOKS, PHD
Regulation Number866.5240
Classification Product Code
CZW  
Date Received04/06/1987
Decision Date 04/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-