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 Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
510(k) Number K203035
Device Name Eonis SCID-SMA kit
Applicant
Perkinelmer, Inc.
940 Winter St.
Waltham,  MA  02451
Applicant Contact Eva Nalian
Correspondent
Perkinelmer, Inc.
940 Winter St.
Waltham,  MA  02451
Correspondent Contact Casey Fox
Regulation Number866.5930
Classification Product Code
PJI  
Date Received10/05/2020
Decision Date 11/09/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Molecular Genetics
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-