PTS Panels® Ketones Test Strips
PTS Panels® Ketone test strips are in vitro diagnostic devices used to monitor ketone levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand…
PTS Panels® Ketone test strips are in vitro diagnostic devices used to monitor ketone levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.
2manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jilin (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Polymer Technology Systems, United States |
|---|---|
| FDA product code | JMK |
| Device type | Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1380 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2016-09-08 |
| Record revised | 2023-07-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight Keep dry; Storage environment temperature 68 to 86 °F; Storage environment temperature 20 to 30 °C |
| Distribution end date | 2017-01-20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1718 | 25 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 13 |
| Liquid Ranbut (RBT) | Randox Laboratories Limited | 2 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K983860 | 1999-12-27 |
| K981865 | 1999-02-26 |
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.