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 Ige, Antigen, Antiserum, Control
510(k) Number K903195
Device Name LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY
Applicant
London Diagnostics, Inc.
10300 Valley View Rd.
Suite 107
Eden Prairie,  MN  55344
Applicant Contact RAMAKRISHMAN
Correspondent
London Diagnostics, Inc.
10300 Valley View Rd.
Suite 107
Eden Prairie,  MN  55344
Correspondent Contact RAMAKRISHMAN
Regulation Number866.5510
Classification Product Code
DGC  
Date Received07/19/1990
Decision Date 08/02/1990
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
-
-