SCL · Class II · 21 CFR 880.5570

FDA Product Code SCL: Allergen And Vaccine Delivery Needles

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.

Leading manufacturers include Asistan Medikal.

1
Total
1
Cleared
305d
Avg days
2026
Since

FDA 510(k) Cleared Allergen And Vaccine Delivery Needles Devices (Product Code SCL)

1 devices
1–1 of 1
Cleared Jan 30, 2026
Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)
K250983
Asistan Medikal
General Hospital · 305d

How to use this database

This page lists all FDA 510(k) submissions for Allergen And Vaccine Delivery Needles devices (product code SCL). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →