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 Ferritin, Antigen, Antiserum, Control
510(k) Number K871489
Device Name DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM
Applicant
Diagnostic Systems Laboratories, Inc.
445 Medical Center Blvd.
Webster,  TX  77598
Applicant Contact GOPAL SAVJANI
Correspondent
Diagnostic Systems Laboratories, Inc.
445 Medical Center Blvd.
Webster,  TX  77598
Correspondent Contact GOPAL SAVJANI
Regulation Number866.5340
Classification Product Code
DBF  
Date Received04/15/1987
Decision Date 06/12/1987
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
-
-