Serum Potassium Reagent Set
510(k) K861713
Serum Potassium Reagent Set is a Class II device made by Sterling Diagnostics Inc, cleared under FDA 510(k) K861713 on 23 May 1986, 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 | FDA 510(k)SESE | NumberK861713 | Date23 May 1986 | StatusActive |
Official records
- FDA 510(k) database K861713
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CEJ
- FDA applicant
- Sterling Diagnostics, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 862.1600
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
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