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Audit Microcv Immunoassay Linearity Set
FDA 510(k)Class I (US FDA 510(k))
510(k) K103601
Identifiers
- 510(k) Number
- K103601 FDA 510(k)
- FDA Product Code
- JJY 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)
The AUDIT MICROCV IMMUNOASSAY LINEARITY SET is a high-precision, clinically validated instrument designed for routine clinical chemistry analysis in laboratories. This device features advanced linearity control, ensuring accurate and reliable results.
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 | K103601 | Class I | Active |
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Manufacturer
- Manufacturer
- Aalto Scientific, Ltd.
Sources (1)
- FDA 510(k) K103601 24 fields · synced Jun 23, 2026