Electrolyte Standard Kit 9200
by Verichem Laboratories, Inc.
Electrolyte Standard Kit 9200 is a Class II device made by Verichem Laboratories, Inc., cleared under FDA 510(k) K112834 on 28 Mar 2012 and listed in FDA GUDID since 16 Jan 2018 (UDI-DI 00852553007162), active as of 22 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 | Number00852553007162 | Date16 Jan 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK112834 | Date28 Mar 2012 | StatusActive |
Official records
- AccessGUDID record 00852553007162
- FDA 510(k) database K112834
Across registries
- FDA 510(k) K112834 decided 28 Mar 2012 Active
- FDA GUDID UDI-DI 00852553007162 listed 16 Jan 2018 Listed
Timeline
- Cleared FDA 510(k) K112834
- Listed FDA GUDID 00852553007162
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Electrolyte Standard Kit
- Generic name
- Multiple electrolyte IVD, calibrator
- Model / reference
- 9200
- Primary DI / UDI-DI
- 00852553007162
- 510(k) Number
- FDA product code
- JIX
- GMDN term
- Multiple electrolyte IVD, calibrator
- Device class
- Class II
- Regulation number
- 862.1150
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Multiple electrolyte IVD, calibrator.