LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set— 510(k) K162959
Substantially EquivalentDiaSorin, Inc.
FDA 510(k) clearance K162959 for LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set, Substantially Equivalent on 2017-01-04. Applicant: DiaSorin, Inc.. Device class: 1.
Clearance details
- Applicant
- DiaSorin, Inc.
- Product code
- Code LSE
- Device class
- Class 1
- Regulation
- 21 CFR 866.3235
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Stillwater, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.