LIAISON® Folate— 510(k) K192586
Substantially EquivalentDiaSorin, Inc.
FDA 510(k) clearance K192586 for LIAISON® Folate, Substantially Equivalent on 2020-05-06. Applicant: DiaSorin, Inc.. Device class: 2.
Clearance details
- Applicant
- DiaSorin, Inc.
- Product code
- Code CGN
- Device class
- Class 2
- Regulation
- 21 CFR 862.1295
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stillwater, MN, US
Recent devices under product code CGN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.