510(k) DEN140010
- Device
- PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
- Applicant
- Wallac OY
- 510(k) number
- DEN140010
- Product code
- PJI
- Decision
- Unknown (DENG)
- Decision date
- 2014-12-15
- Date received
- 2014-02-19
- Regulation
- 866.5930
- Classification name
- Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- KAY A TAYLOR
- Address
- 940 Winter St. Waltham MA US 02451 02451
FDA Registration Numbers#
- 8043909
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PJI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203035 | Eonis SCID-SMA kit | Perkinelmer, Inc. | 2022-11-09 |