Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5570](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5570) → SCL — Allergen And Vaccine Delivery Needles # SCL · Allergen And Vaccine Delivery Needles _General Hospital · 21 CFR 880.5570 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL ## Overview - **Product Code:** SCL - **Device Name:** Allergen And Vaccine Delivery Needles - **Regulation:** [21 CFR 880.5570](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5570) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) - **3rd-party reviewable:** yes ## Identification A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 25) Showing 20 most recent of 25 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250983](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL/K250983.md) | Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) | Asistan Medikal | Jan 30, 2026 | SESE | | [K222385](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL/K222385.md) | Bifurcated Needle | Anhui Tiankang Medical Technology Co., Ltd. | Dec 6, 2022 | SESE | | [K182582](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL/K182582.md) | Oryum and Ovem Epidermal Deri Prick Test Applicator | Allergy & Applicator Depot, LLC | Apr 10, 2019 | SESE | | [K172062](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL/K172062.md) | AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray | Medscience Science Research Group, Inc. | Mar 5, 2018 | SESE | | [K162917](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL/K162917.md) | Allerhope Allergy Skin Tester | Procare Industrial Co., Limited | Aug 17, 2017 | SESE | | [K032528](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL/K032528.md) | BD ECLIPSE BIFURCATED NEEDLE | Becton, Dickinson & CO | Sep 9, 2003 | SESE | | [K031630](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL/K031630.md) | BIFURCATED ALLERGY SKIN TESTING NEEDLE | Precision Medical Products, Inc. | Aug 7, 2003 | SESE | | [K020523](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL/K020523.md) | BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 | Bd | Mar 20, 2002 | SESE | | [K020500](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL/K020500.md) | UNIVEC BIFURCATED SLIDING SHEATH SYRINGE | Univec, Inc. | Mar 19, 2002 | SESE | | [K012515](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL/K012515.md) | BIFURCATED VACCINATING NEEDLE | Precision Medical Products, Inc. | Sep 19, 2001 | SESE | | [K011979](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL/K011979.md) | ALLERSHARP ALLERGY SKIN TESTER | Hmb Medical Concepts, Ltd. | Sep 14, 2001 | SESE | | [K003195](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL/K003195.md) | GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC | Greer Laboratories, Inc. | Dec 13, 2000 | SESE | | [K000299](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL/K000299.md) | DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D | Biomedex, Inc. | Apr 28, 2000 | SESE | | [K982578](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL/K982578.md) | QUANTI-TEST SYSTEM | Panatrex, Inc. | Sep 2, 1998 | SESE | | [K961918](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL/K961918.md) | MULTI-TEST II | Lincoln Diagnostics, Inc. | Aug 7, 1996 | SESE | | [K953939](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL/K953939.md) | QUINTEST | Bayer Corp. | Nov 13, 1995 | SESE | | [K941820](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL/K941820.md) | DUOTIP-TEST | Lincoln Diagnostics, Inc. | Sep 2, 1994 | SESE | | [K922177](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL/K922177.md) | DISPOSABLE MULTI-PUNCTURE APPLICATOR | Allergy Extract Co. | Jun 17, 1993 | SESE | | [K890360](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL/K890360.md) | GREER DERMAPIK SYSTEM | Greer Laboratories, Inc. | Jun 23, 1989 | SESE | | [K882360](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL/K882360.md) | DERMAPIK | Creative Scientific Equipment Corp. | Aug 9, 1988 | SESE | ## Top Applicants - Greer Laboratories, Inc. — 2 clearances - Lincoln Diagnostics, Inc. — 2 clearances - Precision Medical Products, Inc. — 2 clearances - Aller-Screen, Inc. — 1 clearance - Aller/Guard, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/SCL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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