Potassium Electrode 2101
by Medica Corp.
Potassium Electrode 2101 is a Class II device made by Medica Corp., cleared under FDA 510(k) K864872 on 13 Mar 1987 and listed in FDA GUDID since 8 Nov 2018 (UDI-DI 00386100002961), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00386100002961 | Date8 Nov 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK864872 | Date13 Mar 1987 | StatusActive |
Official records
- AccessGUDID record 00386100002961
- FDA 510(k) database K864872
Across registries
- FDA 510(k) K864872 decided 13 Mar 1987 Active
- FDA GUDID UDI-DI 00386100002961 listed 8 Nov 2018 Listed
Timeline
- Cleared FDA 510(k) K864872
- Listed FDA GUDID 00386100002961
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Potassium Electrode
- Generic name
- Potassium (K+) electrode IVD
- Model / Ref / Catalog
- 2101
- Primary DI / UDI-DI
- 00386100002961
- 510(k) Number
- FDA product code
- CEM
- GMDN term
- Potassium (K+) electrode IVD
- Device class
- Class II
- Regulation number
- 862.1600
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Potassium (K+) electrode IVD.