LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus— 510(k) K213858
Substantially EquivalentDiaSorin, Inc.
FDA 510(k) clearance K213858 for LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus, Substantially Equivalent on 2022-07-26. Applicant: DiaSorin, Inc.. Device class: 2.
Clearance details
- Applicant
- DiaSorin, Inc.
- Product code
- Code NXO
- Device class
- Class 2
- Regulation
- 21 CFR 866.5180
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stillwater, MN, US
Recent devices under product code NXO
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Recalls naming K213858
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213858.
Data sourced from openFDA. This site is unofficial and independent of the FDA.