Osmette III 5010F
Osmette III 5010F is a Class I device made by Precision Systems, Inc., listed in FDA GUDID since 14 Oct 2023 (UDI-DI 00850041049847), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850041049847 | Date14 Oct 2023 | StatusListed |
Official records
- AccessGUDID record 00850041049847
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Osmette III
- Generic name
- Osmometric analyser IVD
- Model / Ref / Catalog
- 5010F
- Primary DI / UDI-DI
- 00850041049847
- FDA product code
- JJM
- GMDN term
- Osmometric analyser IVD
- Device class
- Class I
- Regulation number
- 862.2730
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code JJM (Osmometer For Clinical Use).
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- OSMOTIC PRESSURE AUTO & STAT OM-6010 by Kyoto Diagnostics, Inc.