PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM— 510(k) DEN140010
UnknownWallac OY
FDA 510(k) clearance DEN140010 for PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM, Unknown on 2014-12-15. Applicant: Wallac OY. Device class: 2.
Clearance details
- Applicant
- Wallac OY
- Product code
- Code PJI
- Device class
- Class 2
- Regulation
- 21 CFR 866.5930
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Waltham, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.