Newborn Screening Specimen Collection Paper
The Newborn Screening Specimen Collection Paper is a blood collection device intended to collect and transport whole blood specimens from newborns to the laboratory for in vitro diagnostic analysis as part of mandatory newborn screening programs. It is an FDA Class 2 device regulated under 21 CFR 862.1675, requiring 510(k) premarket notification, within the Clinical Chemistry (CH) medical specialty. The product code is PJC. This device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PJC
- Device Class
- FDA class 2
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
Definition
Newborn screening specimen collection paper is a blood collection device intended to be used as medium to collect and transport whole blood specimens from newborns to the laboratory for in vitro diagnostic analysis.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.