LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set— 510(k) K192046
Substantially EquivalentDiaSorin, Inc.
FDA 510(k) clearance K192046 for LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set, Substantially Equivalent on 2019-10-28. Applicant: DiaSorin, Inc.. Device class: 2.
Clearance details
- Applicant
- DiaSorin, Inc.
- Product code
- Code QFO
- Device class
- Class 2
- Regulation
- 21 CFR 866.3935
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stillwater, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.