The following data is part of a premarket notification filed by Perkinelmer Inc with the FDA for Eonis Scid-sma Kit.
| Device ID | K203035 |
| 510k Number | K203035 |
| Device Name: | Eonis SCID-SMA Kit |
| Classification | Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System |
| Applicant | PerkinElmer Inc 940 Winter St Waltham, MA 02451 |
| Contact | Eva Nalian |
| Correspondent | Casey Fox PerkinElmer Inc 940 Winter St Waltham, MA 02451 |
| Product Code | PJI |
| CFR Regulation Number | 866.5930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-05 |
| Decision Date | 2022-11-09 |