DeviceClearance

Product code SCL— General Hospital

ALLER-SCREEN SKIN TEST KIT

Classification name
Allergen And Vaccine Delivery Needles
Device class
Class 2
Regulation
21 CFR 880.5570
Advisory panel
General Hospital
Total cleared
25
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SCL under 21 CFR 880.5570, via openFDA

Market context for product code SCL

FDA has cleared 25 devices under product code SCL between 1976 and 2026, filed by 22 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code SCL

Recent clearances under product code SCL

Data sourced from openFDA. This site is unofficial and independent of the FDA.