PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
FDA 510(k) clearance DEN140010 · decided 2014-12-15
Clearance details
- K-number
- DEN140010
- Device name
- PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
- Applicant
- Wallac OY
- Decision
- Unknown
- Date received
- 2014-02-19
- Decision date
- 2014-12-15
- Days to decision
- 299 days
- Clearance type
- Direct
- 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 |
|---|---|---|
| Eonis SCID-SMA kit (K203035) | Perkinelmer, Inc. | 2022-11-09 |
Recalls involving this device
No recalls on record reference this clearance.