← Back to catalogue
Elitech Clinical Systems Calcium Arsenazo +3 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K110830
by Elitechgroup
Identifiers
- 510(k) Number
- K110830 FDA 510(k)
- FDA Product Code
- CIX FDA 510(k)
- Models / Variants
- Elitech Clinical Systems Calcium Arsenazo FDA 510(k)Elitech Clinical Systems Albumin FDA 510(k)Elitech Clinical Systems Elical 2 FDA 510(k)Elitech FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1035 FDA 510(k)
- Regulation Number
- 862.1035 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Elitech Clinical Systems Calcium Arsenazo +3 more models by Elitechgroup — Class II — FDA_510K — listed in FDA 510(k) — 4 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 | K110830 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Elitechgroup
Sources (1)
- FDA 510(k) K110830 24 fields · synced Jun 18, 2026