Newborn Screening Specimen Collection Paper

PJC · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1675

Classification

FDA Product Code: PJC
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.1675
Review panel: CH
Medical specialty: Clinical Chemistry
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown