SCLClass II
Allergen And Vaccine Delivery Needles
21 CFR 880.5570 / General Hospital
SCL is the FDA product code for Allergen And Vaccine Delivery Needles, a class II device type, regulated under 21 CFR 880.5570. FDA's definition for this code reads: "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". As of , FDA records hold 25 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SCL
- Device name
- Allergen And Vaccine Delivery Needles
- FDA 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.
- Regulation
- 21 CFR 880.5570
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 25
- Ingested recalls
- 0
Clearances, product code SCL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1980 | 1 |
| 1984 | 2 |
| 1985 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 1998 | 1 |
| 2000 | 2 |
| 2001 | 2 |
| 2002 | 2 |
| 2003 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2022 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code SCL| Applicant | Clearances |
|---|---|
| Greer Laboratories Inc | 2 |
| Lincoln Diagnostics, Inc. | 2 |
| Precision Medical Products | 2 |
| Aller-Screen, Inc. | 1 |
| Aller/Guard, Inc. | 1 |
| Allergy & Applicator Depot, LLC | 1 |
| Allergy Extract Co. | 1 |
| Anhui Tiankang Medical Technology Co., Ltd. | 1 |
| Asistan Medikal | 1 |
| Bayer Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Alkaline Corp.
- Allergy & Applicator Depot, LLC
- Anhui Tiankang Medical Technology Co., Ltd.
- BioGeniv, Inc
- Cydonia Pharma SL
- Dongguan King Medical Technology Co.,Ltd
- Dongguan Shun King Company Limited
- Entaco Ltd.
- Greer Laboratories Inc
- International Sterilization Laboratory, LLC
- Isomedix Operations Inc
- Jubilant Hollisterstier LLC
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