Eonis SCID-SMA kit
FDA 510(k) clearance K203035 · decided 2022-11-09
Clearance details
- K-number
- K203035
- Device name
- Eonis SCID-SMA kit
- Applicant
- Perkinelmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-10-05
- Decision date
- 2022-11-09
- Days to decision
- 765 days
- Clearance type
- Traditional
- Product code
- PJI
- Device class
- 2
- Regulation number
- 866.5930
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM (DEN140010) | Wallac OY | 2014-12-15 |
Recalls involving this device
No recalls on record reference this clearance.