Allergen And Vaccine Delivery Needles

SCL · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5570

Classification

FDA Product Code: SCL
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.5570
Review panel: HO
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

An allergen delivery needle is a device intended to percutaneously deliver diagnostic allergenic extracts for use in allergy skin tests also referred to as skin prick tests or intradermal allergy tests.

Market data

Cleared 510(k) submissions: 25
Registered establishments: 23

Source

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