Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)
FDA 510(k) K250983 · Asistan Medikal
510(k) numberK250983
Submission
- Device name
- Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)
- Applicant
- Asistan Medikal
Oguzeli, Gaziantep, TR - Received
- March 31, 2025
- Decision date
- January 30, 2026
- 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 |
|---|---|---|---|
| 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 |
| 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 Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) cleared by the FDA?
Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) (K250983) received a 510(k) decision of Substantially Equivalent on January 30, 2026, 305 days after the submission was received.
What is the product code of K250983?
The FDA product code is SCL – Allergen And Vaccine Delivery Needles, a Class II (moderate risk) device regulated under 21 CFR 880.5570.