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 Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
510(k) Number K971689
Device Name IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT
Applicant
Euro-Diagnostica AB
155 Cider Mill Rd.
Ringoes,  NJ  08551
Applicant Contact KARL A POSSELT
Correspondent
Euro-Diagnostica AB
155 Cider Mill Rd.
Ringoes,  NJ  08551
Correspondent Contact KARL A POSSELT
Regulation Number866.5660
Classification Product Code
MOB  
Date Received05/07/1997
Decision Date 10/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-