Product code SCL
- Device name
- Allergen And Vaccine Delivery Needles
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5570
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250983 | Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) | Asistan Medikal | 2026-01-30 |
| K222385 | Bifurcated Needle | Anhui Tiankang Medical Technology Co., Ltd. | 2022-12-06 |
| K182582 | Oryum and Ovem Epidermal Deri Prick Test Applicator | Allergy & Applicator Depot, LLC | 2019-04-10 |
| K172062 | AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray | Medscience Science Research Group, Inc. | 2018-03-05 |
| K162917 | Allerhope Allergy Skin Tester | Procare Industrial Co., Limited | 2017-08-17 |
| K032528 | BD ECLIPSE BIFURCATED NEEDLE | Becton, Dickinson & CO | 2003-09-09 |
| K031630 | BIFURCATED ALLERGY SKIN TESTING NEEDLE | Precision Medical Products, Inc. | 2003-08-07 |
| K020523 | BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 | Bd | 2002-03-20 |
| K020500 | UNIVEC BIFURCATED SLIDING SHEATH SYRINGE | Univec, Inc. | 2002-03-19 |
| K012515 | BIFURCATED VACCINATING NEEDLE | Precision Medical Products, Inc. | 2001-09-19 |
| K011979 | ALLERSHARP ALLERGY SKIN TESTER | Hmb Medical Concepts, Ltd. | 2001-09-14 |
| K003195 | GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC | Greer Laboratories, Inc. | 2000-12-13 |
| K000299 | DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D | Biomedex, Inc. | 2000-04-28 |
| K982578 | QUANTI-TEST SYSTEM | Panatrex, Inc. | 1998-09-02 |
| K961918 | MULTI-TEST II | Lincoln Diagnostics, Inc. | 1996-08-07 |
| K953939 | QUINTEST | Bayer Corp. | 1995-11-13 |
| K941820 | DUOTIP-TEST | Lincoln Diagnostics, Inc. | 1994-09-02 |
| K922177 | DISPOSABLE MULTI-PUNCTURE APPLICATOR | Allergy Extract Co. | 1993-06-17 |
| K890360 | GREER DERMAPIK SYSTEM | Greer Laboratories, Inc. | 1989-06-23 |
| K882360 | DERMAPIK | Creative Scientific Equipment Corp. | 1988-08-09 |
| K844221 | HMB ALLERGOGEN SKIN PRICK TEST NEEDLE | Aller/Guard, Inc. | 1985-02-08 |
| K833999 | COMBION SKIN TEST - FOUR PRONG | Nicholas H. Maganias | 1984-09-05 |
| K842107 | COMBO SKIN TEST READY TO USE TAPE | Combion Systems, Inc. | 1984-09-05 |
| K791328 | ALLER-SCREEN SKIN TEST KIT | Aller-Screen, Inc. | 1980-05-30 |
| K760699 | MULTI-TEST | Lincoln Laboratories, Inc. | 1976-12-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00892093002029 | Multi-Test II Skin Test System | Lincoln Diagnostics, Inc. | 2025-12-12 |
| 00892093002036 | Multi-Test II Skin Test System | Lincoln Diagnostics, Inc. | 2025-12-12 |
| 00892093002005 | Multi-Test Skin Test System | Lincoln Diagnostics, Inc. | 2025-12-12 |
| 00892093002012 | Multi-Test Skin Test System | Lincoln Diagnostics, Inc. | 2025-12-12 |
| 00892093002142 | Multi-Test II Skin Test System | Lincoln Diagnostics, Inc. | 2025-12-12 |
| 00892093002043 | Duotip-Test Skin Test System | Lincoln Diagnostics, Inc. | 2025-12-12 |
| 00892093002050 | Duotip-Test II Skin Test System | Lincoln Diagnostics, Inc. | 2025-12-12 |
| 00892093002067 | Multi-Test Dipwell Tray | Lincoln Diagnostics, Inc. | 2025-12-12 |
| 00892093002074 | Multi-Test Dipwell Tray, non-capped | Lincoln Diagnostics, Inc. | 2025-12-12 |
| 00892093002081 | Duotip-Test Dipwell Tray | Lincoln Diagnostics, Inc. | 2025-12-12 |
| 00892093002098 | Wells for Pyramid Dipwell Tray | Lincoln Diagnostics, Inc. | 2025-12-12 |
| 00892093002111 | Multi-Test PC Skin Test System | Lincoln Diagnostics, Inc. | 2025-12-12 |
| 00892093002128 | UniTest PC Skin Test System | Lincoln Diagnostics, Inc. | 2025-12-12 |
| 00892093002135 | Multi-Test PC Skin Test System | Lincoln Diagnostics, Inc. | 2025-12-12 |