Nova/Stat Profile
Preheater Deproteinizing Solution
1manufacturer
1catalogue number
6510(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 | Nova Biomedical Corporation, United States |
|---|---|
| FDA product code | JFP |
| Device type | Electrode, Ion Specific, Calcium |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1145 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K963005 |
| Record published | 2016-09-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 30 °C; Handling environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1 | 30 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 9 |
| Nova | Nova Biomedical Corporation | 8 |
| Calcium Electrode | Medica Corp. | 2 |
| SC90 | Radiometer Medical APS | 2 |
| pH/pCO2/pO2/Na/K/Ca Analyzer | Medica Corp. | 2 |
| Na/K/Cl/Ca/Li Solution pack | Medica Corp. | 1 |
| Rinse Solution S4980 REF 944-130 | Radiometer Medical APS | 1 |
| Rapidpoint® 350 Sampler Module | Siemens Healthcare Diagnostics Inc | 1 |
| RAPIDLab® 1200 pH Electrode Fill | Siemens Healthcare Diagnostics Inc | 1 |
| Roche 9180 Electrolyte Analyzer | Roche Diagnostics Gmbh | 1 |
| E-Ca Cassette Carton | Opti Medical Systems Inc. | 1 |
| Calcium Reference Electrode | Medica Corp. | 1 |
Showing 12 of 33. All products under Electrode, Ion Specific, Calcium
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191626 | 2019-08-16 |
| K960120 | 1996-03-11 |
| K830213 | 1983-04-05 |
| K830502 | 1983-03-24 |
| K823389 | 1983-02-02 |
| K771643 | 1977-09-28 |
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.