510(k) K203035
- Device
- Eonis SCID-SMA Kit
- Applicant
- PerkinElmer Inc
- 510(k) number
- K203035
- Product code
- PJI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-11-09
- Date received
- 2020-10-05
- Regulation
- 866.5930
- Classification name
- Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System
- Medical specialty
- Immunology
- Review panel
- Molecular Genetics
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Eva Nalian
- Address
- 940 Winter St. Waltham MA US 02451 02451
FDA Registration Numbers#
- 8043909
Source Documents#
Other 510(k) Records For Product Code PJI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN140010 | PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM | Wallac OY | 2014-12-15 |
Legacy Summary#
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FDA Review#
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