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 Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
510(k) Number K141827
Device Name EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE
Applicant
EUROIMMUN U.S., Inc.
1100 THE AMERICAN ROAD
MORRIS PLAINS,  NJ  07950
Applicant Contact MICHAEL A LOCKE
Correspondent
EUROIMMUN U.S., Inc.
1100 THE AMERICAN ROAD
MORRIS PLAINS,  NJ  07950
Correspondent Contact MICHAEL A LOCKE
Regulation Number866.5100
Classification Product Code
DHN  
Subsequent Product Code
PIV  
Date Received07/07/2014
Decision Date 04/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-