Bifurcated Allergy Skin Testing Needle
FDA 510(k) K031630 · Precision Medical Products, Inc.
510(k) numberK031630
Submission
- Device name
- Bifurcated Allergy Skin Testing Needle
- Applicant
- Precision Medical Products, Inc.
Denver, PA, US - Received
- May 27, 2003
- Decision date
- August 7, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K162917 | Allerhope Allergy Skin TesterSCL · Traditional | Procare Industrial Co., Limited | 08/17/2017SE |
| K032528 | BD Eclipse Bifurcated NeedleSCL · Special | Becton, Dickinson & CO | 09/09/2003SE |
| 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 |
More from Hmb Medical Concepts, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K012515 | Bifurcated Vaccinating NeedleSCL · Traditional | 09/19/2001SE |
Questions and answers
When was Bifurcated Allergy Skin Testing Needle cleared by the FDA?
Bifurcated Allergy Skin Testing Needle (K031630) received a 510(k) decision of Substantially Equivalent on August 7, 2003, 72 days after the submission was received.
What is the product code of K031630?
The FDA product code is SCL – Allergen And Vaccine Delivery Needles, a Class II (moderate risk) device regulated under 21 CFR 880.5570.