SCL — Allergen And Vaccine Delivery Needles Class II
FDA product code SCL covers "Allergen And Vaccine Delivery Needles", a Class II medical device regulated under 21 CFR 880.5570. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SCL
- Device Class
- Class II
- Regulation Number
- 880.5570
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250983 | asistan medikal | Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS | January 30, 2026 |
| K222385 | anhui tiankang medical technology co | Bifurcated Needle | December 6, 2022 |
| K182582 | allergy and applicator depot | Oryum and Ovem Epidermal Deri Prick Test Applicator | April 10, 2019 |
| K172062 | medscience science research group | AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Tes | March 5, 2018 |
| K162917 | procare industrial co., limited | Allerhope Allergy Skin Tester | August 17, 2017 |
| K032528 | becton, dickinson and | BD ECLIPSE BIFURCATED NEEDLE | September 9, 2003 |
| K031630 | precision medical products | BIFURCATED ALLERGY SKIN TESTING NEEDLE | August 7, 2003 |
| K020523 | bd | BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 | March 20, 2002 |
| K020500 | univec | UNIVEC BIFURCATED SLIDING SHEATH SYRINGE | March 19, 2002 |
| K012515 | precision medical products | BIFURCATED VACCINATING NEEDLE | September 19, 2001 |
| K011979 | hmb medical concepts | ALLERSHARP ALLERGY SKIN TESTER | September 14, 2001 |
| K003195 | greer laboratories | GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC | December 13, 2000 |
| K000299 | biomedex | DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULT | April 28, 2000 |
| K982578 | panatrex | QUANTI-TEST SYSTEM | September 2, 1998 |
| K961918 | lincoln diagnostics | MULTI-TEST II | August 7, 1996 |
| K953939 | bayer | QUINTEST | November 13, 1995 |
| K941820 | lincoln diagnostics | DUOTIP-TEST | September 2, 1994 |
| K922177 | allergy extract | DISPOSABLE MULTI-PUNCTURE APPLICATOR | June 17, 1993 |
| K890360 | greer laboratories | GREER DERMAPIK SYSTEM | June 23, 1989 |
| K882360 | creative scientific equipment | DERMAPIK | August 9, 1988 |