Zip Zone Sponge Wicks
Catalogue number 9014, listed by Helena Laboratories, Corp., United States, under Apparatus, Electrophoresis, For Clinical Use. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
8510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (3), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
Record
| Listed by | Helena Laboratories, Corp., United States |
|---|---|
| FDA product code | JJN |
| Device type | Apparatus, Electrophoresis, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2485 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-03-17 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9014 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Micro SSP™ Gel System – 108 Wells | ONE Lambda, Inc. | 1 |
| Migele Gel Electrophoresis Unit | Wallac OY | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K881852 | 1988-07-08 |
| K882163 | 1988-06-20 |
| K873352 | 1987-09-08 |
| K861414 | 1986-08-26 |
| K821688 | 1982-06-22 |
| K821517 | 1982-06-10 |
| K803281 | 1981-01-16 |
| K791144 | 1979-08-03 |
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.