COPALIS EBV-M ANTIBODY ASSAY— 510(k) K991459
Substantially EquivalentDiaSorin, Inc.
FDA 510(k) clearance K991459 for COPALIS EBV-M ANTIBODY ASSAY, Substantially Equivalent on 1999-05-14. Applicant: DiaSorin, Inc.. Device class: 1.
Clearance details
- Applicant
- DiaSorin, Inc.
- Product code
- Code LJN
- Device class
- Class 1
- Regulation
- 21 CFR 866.3235
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Columbia, MD, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.