Phoenix Diagnostics
LiquiCV STAT - Blood Gas / Electrolyte / Metabolite Linearity Control for Abbott iSTAT
1manufacturer
11catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Phoenix Diagnostics, Inc., United States |
|---|---|
| FDA product code | JJS |
| Device type | Controls For Blood-Gases, (Assayed And Unassayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Manufacturer |
| 510(k) | K920285 |
| Record published | 2023-08-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Handling environment temperature 15 to 30 °C |
| Sizes | Total volume 2 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1008AM | Total Volume 2 ml | 30 | In distribution |
| 1004P | Total Volume 2 ml | 30 | In distribution |
| PD500A | Total Volume 2 ml | 20 | In distribution |
| 1003P | Total Volume 2 ml | 30 | In distribution |
| 1007AM | Total Volume 2 ml | 30 | In distribution |
| 1006AM | Total Volume 2 ml | 30 | In distribution |
| 1001P | Total Volume 2 ml | 30 | In distribution |
| PD500S | Total Volume 2 ml | 20 | In distribution |
| PH5001 | Total Volume 2 ml | 15 | In distribution |
| 1002P | Total Volume 2 ml | 30 | In distribution |
| 1009AM | Total Volume 2 ml | 30 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Liquichek | Bio-Rad Laboratories Inc. | 16 |
| Architect | Abbott Laboratories | 7 |
| Stat Profile | Nova Biomedical Corporation | 7 |
| Blood Gas and Electrolyte Control | Edan Instruments, Inc. | 3 |
| VKR-7 | Radiometer America, Inc. | 1 |
| Mission Control, Level 1 | Diamond Diagnostics Inc. | 1 |
| Autocheck 3+, Level 1, S7335 | Radiometer Medical APS | 1 |
| Autocheck 3+, Level 4, S7365 | Radiometer Medical APS | 1 |
| Qualicheck 5+, Level 4 | Radiometer Medical APS | 1 |
| Qualicheck 5+, Level 3 | Radiometer Medical APS | 1 |
| QC Adaptor | Radiometer Medical APS | 1 |
| Qualicheck 4+, Level 2 | Radiometer Medical APS | 1 |
Showing 12 of 45. All products under Controls For Blood-Gases, (Assayed And Unassayed)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K945860 | 1995-01-17 |
| K920285 | 1992-07-14 |
| K901985 | 1990-06-06 |
| K901986 | 1990-05-31 |
| K901976 | 1990-05-31 |
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.