MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C— 510(k) K124009
Substantially EquivalentDiamond Diagnostics, Inc.
FDA 510(k) clearance K124009 for MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C, Substantially Equivalent on 2013-04-17. Applicant: Diamond Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Diamond Diagnostics, Inc.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Holliston, MA, US
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