Poch-Pack D
Diluent for the pocH-100i hematology analyzer
5manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Shandong (3), Guangdong (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| B&E BIO-Technology Co., Ltd. | Yantai | Shandong | Manufacturer | 9 |
Record
| Listed by | Sysmex Corporation, Japan |
|---|---|
| FDA product code | GIF |
| Device type | Diluent, Blood Cell |
| Device class | Class 1 |
| Regulation | 21 CFR 864.8200 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-11-04 |
| Record revised | 2023-06-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 1 to 30 °C |
| Sizes | Total volume 2 l |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PPD-300A | Total Volume 2 l | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cell-DYN | Abbott Laboratories | 7 |
| Cardinal Health | Cardinal Health 200, LLC | 5 |
| Cellpack | Sysmex Corporation | 4 |
| Cellpack DST | Sysmex Corporation | 4 |
| Drew Scientific | Drew Scientific, Ltd. | 3 |
| Atellica IM Multi-Diluent 1 | Siemens Healthcare Diagnostics Inc | 3 |
| Cellpack DCL | Sysmex Corporation | 3 |
| SP | Cardinal Health 200, LLC | 3 |
| Needle Holder | Koros U.S.A., Inc. | 3 |
| Advia Centaur® Multi-Diluent 1 | Siemens Healthcare Diagnostics Inc | 3 |
| UF II Pack-SED | Sysmex Corporation | 2 |
| Cellsheath | Sysmex Corporation | 2 |
Showing 12 of 88. All products under Diluent, Blood Cell
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K790028 | 1979-02-15 |
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.