FreezePoint® Freezing Point Osmometer
FreezePoint® Freezing Point Osmometer is intended for laboratory use by qualified personnel for the determination of total osmolality of aqueous solutions.
4manufacturers in China registered for this device type
4catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Shandong (2), Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
Record
| Listed by | ELITechGroup Inc, United States |
|---|---|
| FDA product code | JJM |
| Device type | Osmometer For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2730 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-02-17 |
| Record revised | 2023-08-14 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Handling environment temperature 10 to 30 °C; Handling environment humidity up to 80 % RH; Storage environment humidity up to 80 % RH; Storage environment temperature -10 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Model 6000SP | In distribution | |
| Model 6000S | In distribution | |
| Model 6000P | In distribution | |
| Model 6000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Multi-OSMETTE | Precision Systems, Inc. | 3 |
| Micro-OSMETTE | Precision Systems, Inc. | 2 |
| Advanced Instruments OsmoPRO Multi-Sample Micro-Osmometer | Advanced Instruments, LLC | 2 |
| Osmette Sample Tubes, 30 ul | Precision Systems, Inc. | 2 |
| Osmette III | Precision Systems, Inc. | 2 |
| Osmette XL | Precision Systems, Inc. | 2 |
| Advanced Instruments Model 3250 Single-Sample Osmometer Sample Tubes, Box of 500 | Advanced Instruments, LLC | 2 |
| Osmette A | Precision Systems, Inc. | 2 |
| Touch Micro-OSMETTE | Precision Systems, Inc. | 1 |
| Multi-OSMETTE Carousel, Spare | Precision Systems, Inc. | 1 |
| Micro-OSMETTE Sample Tubes, 50 ul | Precision Systems, Inc. | 1 |
| Osmette III 10 ul Pipet Piston 2/pk | Precision Systems, Inc. | 1 |
Showing 12 of 60. All products under Osmometer For Clinical Use
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-12-26 | Not classified | Nonconforming Material/Component | Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing. | 75 vials | 2008-03-27 |
| 2007-12-26 | Not classified | Nonconforming Material/Component | Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing. | 950 vials | 2008-03-27 |
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.