Pointe Scientific
ISE Standard - Low For the standardization of Sodium, Potassium and Chloride on Ion Selective Electrodes. packaged at 10 x 2ml
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
1recall
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Horiba Instruments Incorporated, United States |
|---|---|
| FDA product code | JGS |
| Device type | Electrode, Ion Specific, Sodium |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1665 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K051646 |
| Record published | 2016-08-31 |
| Record revised | 2025-10-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HI790-STL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 13 |
| i-STAT | Abbott Point OF Care Inc. | 9 |
| AU | Beckman Coulter, Inc. | 8 |
| GEM Premier ChemSTAT PAK Na+,K+,Ca++,Cl-, Glu, Crea, BUN, tCO2, Hct, Lac,pH,pCO2 | Instrumentation Laboratory SPA | 8 |
| Nova | Nova Biomedical Corporation | 6 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 5 |
| Sodium Electrode | Roche Diagnostics Gmbh | 4 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 3 |
| Architect | Abbott Laboratories | 3 |
| Synermed® | Infrared Laboratory Systems LLC | 3 |
| Sodium Electrode | Diamond Diagnostics Inc. | 3 |
| Phoenix Diagnostics | Phoenix Diagnostics, Inc. | 2 |
Showing 12 of 88. All products under Electrode, Ion Specific, Sodium
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K841424 | 1984-06-22 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-03-20 | Class II | Software design | HORIBA Medical is informing all ABX PENTRA 400 Analyzer with I.S.E. Module customers that there are no Linearity Limit Flags for the I.S.E. assays currently programmed into the ABX PENTRA 400 Analyzer software. All other assays run on this | 905 units | 2014-09-26 |
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.