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 Anti-Phospholipase A2 Receptor
510(k) Number K132195
Device Name EUROIMMUN ANTI-PLA2R ELISA (IGG)
Applicant
Euroimmun Us, Inc.
1100 The American Rd.
Morris Plains,  NJ  07950
Applicant Contact MICHAEL LOCKE
Correspondent
Euroimmun Us, Inc.
1100 The American Rd.
Morris Plains,  NJ  07950
Correspondent Contact MICHAEL LOCKE
Classification Product Code
PGV  
Date Received07/15/2013
Decision Date 06/27/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
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
-
-