SCL

Allergen And Vaccine Delivery Needles

Product code

SCL

Device name

Allergen And Vaccine Delivery Needles

Device class

Class 2

21 CFR

21 CFR 880.5570

Medical specialty

General Hospital

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

25 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-01-30.

1 summaries are archived here for direct download.