Allergen and Vaccine Delivery Needles

What Is It?

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.

What Is FDA Product Code SCL?

Allergen And Vaccine Delivery Needles is FDA product code SCL, Class 2, 21 CFR 880.5570.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 2 clearances under this code; the FDA took a median of 211 days from receipt to decision on them.