Eonis SCID-SMA kit
FDA 510(k) K203035 · Perkinelmer, Inc.
510(k) numberK203035
Submission
- Device name
- Eonis SCID-SMA kit
- Applicant
- Perkinelmer, Inc.
Waltham, MA, US - Received
- October 5, 2020
- Decision date
- November 9, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PJI – Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5930
- Specialty
- Immunology
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).
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Questions and answers
When was Eonis SCID-SMA kit cleared by the FDA?
Eonis SCID-SMA kit (K203035) received a 510(k) decision of Substantially Equivalent on November 9, 2022, 765 days after the submission was received.
What is the product code of K203035?
The FDA product code is PJI – Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System, a Class II (moderate risk) device regulated under 21 CFR 866.5930.