FDA device listing

AllerTest Multiple Well Test Tray,AllerTest Skin Test Applicator,ST-9 Multiple Well Test Tray,ST-9 Skin Test…

FDA device listing 1795881667 · Medscience Research Group, Inc.

Key facts

Proprietary names AllerTest Multiple Well Test Tray,AllerTest Skin Test Applicator,ST-9 Multiple Well Test Tray,ST-9 Skin Test Applicator,ST Single Head Skin Test Applicator
Owner/operator Medscience Research Group, Inc.
Owner/operator number 10058191
Premarket submissions K172062
Product codes SCL
Device names SCL - Allergen And Vaccine Delivery Needles
Device class Class II
Classification regulations (21 CFR) 880.5570
Review panels General Hospital
Registered establishments MEDSCIENCE RESEARCH GROUP, INC.
Establishment registrations 3010131789
FEI numbers 3010131789
Establishment operations Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device listings