MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL— 510(k) K103364
Substantially EquivalentDiamond Diagnostics, Inc.
FDA 510(k) clearance K103364 for MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL, Substantially Equivalent on 2011-05-06. 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.