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 K034057
Device Name LACRYTEST
Applicant
Adiatec SA
5 Passage Douard
4 Rue Des Olivettes
Nantes,  FR 44000
Applicant Contact JOEL LESSER
Correspondent
Adiatec SA
5 Passage Douard
4 Rue Des Olivettes
Nantes,  FR 44000
Correspondent Contact JOEL LESSER
Regulation Number866.5510
Classification Product Code
DGC  
Date Received12/30/2003
Decision Date 03/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-