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 Serpina1 Variant Detection System
510(k) Number K192858
Device Name A1AT Genotyping Test
Applicant
Progenika Biopharma S.A., A Grifols Company
Ibaizabal Bidea, Edificio 504, Parque Tecnologico De Bizkaia
Derio,  ES 48160
Applicant Contact Diego Tejedor
Correspondent
Progenika Biopharma S.A., A Grifols Company
Ibaizabal Bidea, Edificio 504, Parque Tecnologico De Bizkaia
Derio,  ES 48160
Correspondent Contact Diego Tejedor
Regulation Number866.5130
Classification Product Code
PZH  
Date Received10/04/2019
Decision Date 11/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-