Spotcheck
315-2 Detector, 110 Volt with Tungsten
9manufacturers in China registered for this device type
18catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (3), Guangdong (2), Jilin (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yantai Addcare Bio-Tech Co., Ltd. | Yantai | Shandong | Contract manufacturer | 8 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Nanning Tecbod Biological Technology Co., Ltd. | Nanning | Guangxi | Contract manufacturer | 51 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
| Aikang Medtech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 5 |
| Shenzhen Well Electric Co., Limited | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Astoria-Pacific, Inc., United States |
|---|---|
| FDA product code | JJC |
| Device type | Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2150 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K101392 |
| Record published | 2016-10-14 |
| Record revised | 2022-09-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 315-A110-VS2 | In distribution | |
| 307-A001-03 | In distribution | |
| 302-A100-03 | In distribution | |
| 303-A004-03 | In distribution | |
| 307-A980-00A | In distribution | |
| 303-A002-03 | In distribution | |
| 361-A803-00 | In distribution | |
| 307-C001-00 | In distribution | |
| 307-A001-02 | In distribution | |
| 307-A950-04 | In distribution | |
| 307-A980-00B | In distribution | |
| 307-A001-01 | In distribution | |
| 315-A995-00 | In distribution | |
| 307-A990-00 | In distribution | |
| 303-A003-03 | In distribution | |
| 302-A100-03EX | In distribution | |
| 303-A000-03 | In distribution | |
| 307-A950-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Caplugs/Evergreen | Caplugs, Inc. | 50 |
| Nova | Nova Biomedical Corporation | 3 |
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.