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Hemocue Hb 301 Analyzer (121804 +2 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K061047
by Hemocue AB
Identifiers
- 510(k) Number
- K061047 FDA 510(k)
- FDA Product Code
- GKR FDA 510(k)
- Models / Variants
- 121804 FDA 510(k)Microcuvettes FDA 510(k)Model 111801 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5620 FDA 510(k)
- Regulation Number
- 864.5620 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Hemocue Hb 301 Analyzer (121804 +2 more) by Hemocue AB — Class II — FDA_510K — listed in FDA 510(k) — 3 models — regulatory data on deviCERTS
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 | K061047 | Class II | Active |
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Manufacturer
- Manufacturer
- Hemocue AB
Sources (1)
- FDA 510(k) K061047 24 fields · synced Jun 19, 2026