Allerhope Allergy Skin Tester
FDA 510(k) K162917 · Procare Industrial Co., Limited
510(k) numberK162917
Submission
- Device name
- Allerhope Allergy Skin Tester
- Applicant
- Procare Industrial Co., Limited
Zhengzhou, CN - Received
- October 18, 2016
- Decision date
- August 17, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SCL – Allergen And Vaccine Delivery Needles
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
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.
Other 510(k)s with product code SCL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250983 | Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132…SCL · Traditional | Asistan Medikal | 01/30/2026SE |
| K222385 | Bifurcated NeedleSCL · Traditional | Anhui Tiankang Medical Technology Co., Ltd. | 12/06/2022SE |
| K182582 | Oryum and Ovem Epidermal Deri Prick Test ApplicatorSCL · Traditional | Allergy & Applicator Depot, LLC | 04/10/2019SE |
| K172062 | AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test TraySCL · Traditional | Medscience Science Research Group, Inc. | 03/05/2018SE |
| K032528 | BD Eclipse Bifurcated NeedleSCL · Special | Becton, Dickinson & CO | 09/09/2003SE |
| K031630 | Bifurcated Allergy Skin Testing NeedleSCL · Traditional | Precision Medical Products, Inc. | 08/07/2003SE |
| K020523 | BD Bifurcated Needle, Models 301754, 301755, 301756, 301757SCL · Traditional | Bd | 03/20/2002SE |
| K020500 | Univec Bifurcated Sliding Sheath SyringeSCL · Traditional | Univec, Inc. | 03/19/2002SE |
| K012515 | Bifurcated Vaccinating NeedleSCL · Traditional | Precision Medical Products, Inc. | 09/19/2001SE |
| K011979 | Allersharp Allergy Skin TesterSCL · Traditional | Hmb Medical Concepts, Ltd. | 09/14/2001SE |
Questions and answers
When was Allerhope Allergy Skin Tester cleared by the FDA?
Allerhope Allergy Skin Tester (K162917) received a 510(k) decision of Substantially Equivalent on August 17, 2017, 303 days after the submission was received.
What is the product code of K162917?
The FDA product code is SCL – Allergen And Vaccine Delivery Needles, a Class II (moderate risk) device regulated under 21 CFR 880.5570.