LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871— 510(k) K062473
Substantially EquivalentDiaSorin, Inc.
FDA 510(k) clearance K062473 for LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871, Substantially Equivalent on 2007-04-12. 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.