LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set— 510(k) K193051
Substantially EquivalentDiaSorin, Inc.
FDA 510(k) clearance K193051 for LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set, Substantially Equivalent on 2020-01-29. Applicant: DiaSorin, Inc.. Device class: 2.
Clearance details
- Applicant
- DiaSorin, Inc.
- Product code
- Code LSR
- Device class
- Class 2
- Regulation
- 21 CFR 866.3830
- 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.