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Cardiac Markers Control (single Use)-Levels, 1, 2, 3 (Number 175-1 +2 more)
FDA 510(k)Class I (US FDA 510(k))
510(k) K982845
Identifiers
- 510(k) Number
- K982845 FDA 510(k)
- FDA Product Code
- JJT FDA 510(k)
- Models / Variants
- Number 175-1 FDA 510(k)175-2 FDA 510(k)175-3 FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1660 FDA 510(k)
- Regulation Number
- 862.1660 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Cardiac Markers Control (single Use)-Levels, 1, 2, 3 (Number 175-1 +2 more) by More Diagnostics Inc — Class I — FDA_510K — listed in FDA 510(k) — 3 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K982845 | Class I | Active |
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Manufacturer
- Manufacturer
- More Diagnostics Inc
- FDA Applicant
- More Diagnostics
Sources (1)
- FDA 510(k) K982845 24 fields · synced Jun 18, 2026