POTASSIUM TEST— 510(k) K811661
Substantially EquivalentKing Diagnostics, Inc.
FDA 510(k) clearance K811661 for POTASSIUM TEST, Substantially Equivalent on 1981-06-25. Applicant: King Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- King Diagnostics, Inc.
- Product code
- Code CEJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1600
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code CEJ
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