Cleared Traditional

Eonis SCID-SMA kit

K203035 · Perkinelmer, Inc. · Medical Genetics
Nov 2022
Decision
765d
Days
Class 2
Risk

About This 510(k) Submission

K203035 is an FDA 510(k) clearance for the Eonis SCID-SMA kit, a Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System (Class II — Special Controls, product code PJI), submitted by Perkinelmer, Inc. (Waltham, US). The FDA issued a Cleared decision on November 9, 2022, 765 days after receiving the submission on October 5, 2020. This device falls under the Medical Genetics review panel. Regulated under 21 CFR 866.5930.

Submission Details

510(k) Number K203035 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 2020
Decision Date November 09, 2022
Days to Decision 765 days
Submission Type Traditional
Review Panel Medical Genetics (MG)
Summary Summary PDF

Device Classification

Product Code PJI — Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5930
Definition A Newborn Screening Test For Severe Combined Immunodeficiency (scid) Intended For The Detection Of T-cell Receptor Excision Circle (trec) Genomic Dna Isolated From Newborn Blood Specimens Dried On Filter Paper. It Is Intended As An Aid In Screening Newborns For Severe Combined Immunodeficiency (scid).