Multi-Test II Skin Test System
Multiple skin test applicator for allergy testing, case of 600.
4manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (2), Anhui (1), Henan (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Shun King Company Limited | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Anhui Tiankang Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 9 |
| Procare Industrial Co., Limited | Zhengzhou | Henan | Manufacturer | 3 |
Record
| Listed by | Lincoln Diagnostics, Inc., United States |
|---|---|
| FDA product code | SCL |
| Device type | Allergen And Vaccine Delivery Needles |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Manufacturer |
| 510(k) | K961918 |
| Record published | 2025-12-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MH-II 6 | 6 | In distribution | |
| MH-II BLK | 600 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Multi-Test PC Skin Test System | Lincoln Diagnostics, Inc. | 2 |
| Multi-Test Skin Test System | Lincoln Diagnostics, Inc. | 2 |
| Duotip-Test Skin Test System | Lincoln Diagnostics, Inc. | 1 |
| Multi-Test Dipwell Tray, non-capped | Lincoln Diagnostics, Inc. | 1 |
| Duotip-Test Dipwell Tray | Lincoln Diagnostics, Inc. | 1 |
| Duotip-Test II Skin Test System | Lincoln Diagnostics, Inc. | 1 |
| Wells for Pyramid Dipwell Tray | Lincoln Diagnostics, Inc. | 1 |
| UniTest PC Skin Test System | Lincoln Diagnostics, Inc. | 1 |
| Multi-Test Dipwell Tray | Lincoln Diagnostics, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K961918 | 1996-08-07 |
| K941820 | 1994-09-02 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.