Transparent Disp. Tube Tolders (For HemataSTAT, Cream 50/pkg)
Catalogue number 230-100, listed by Separation Technology, Inc., United States, under Centrifuge, Hematocrit. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1), Hunan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Hunan Xiang YI Laboratory Instrument Development Co., Ltd. | Changsha | Hunan | Manufacturer | 7 |
| Zhejiang Huawei Scientific Instrument Co Ltd | Linhai | Zhejiang | Manufacturer | 4 |
Record
| Listed by | Separation Technology, Inc., United States |
|---|---|
| FDA product code | GKG |
| Device type | Centrifuge, Hematocrit |
| Device class | Class 2 |
| Regulation | 21 CFR 864.6400 |
| Premarket notification | Exempt |
| Record published | 2017-08-25 |
| Record revised | 2018-04-18 (version 3) |
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 | Per pack | Status |
|---|---|---|---|
| 230-100 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bucket | Andreas Hettich Gmbh | 12 |
| Angle rotor | Andreas Hettich Gmbh | 11 |
| Swing-out rotor | Andreas Hettich Gmbh | 6 |
| LW Scientific, Inc. | LW Scientific, Inc. | 5 |
| Globe Scientific | Globe Scientific, LLC | 4 |
| QBC Diagnostics | Drucker Diagnostics, LLC | 2 |
| Combo V24T Centrifuge,12-pl test tube and 24-pl hematocrit rotors w/ tach, 110v | LW Scientific, Inc. | 2 |
| Unico Powerspin BX | United Products & Instruments, Inc. | 2 |
| Combo V24 Centrifuge,12-place test tube and 24-place hematocrit rotors, 220v | LW Scientific, Inc. | 2 |
| HemataSTAT II Centrifuge | Separation Technology, Inc. | 2 |
| CC Cartridge | LifeHealth, LLC | 2 |
| E8 Combination Centrifuge, digital | LW Scientific, Inc. | 2 |
Showing 12 of 37. All products under Centrifuge, Hematocrit
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K913128 | 1991-09-23 |
| K890849 | 1989-03-21 |
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.