MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET— 510(k) K001118
Substantially EquivalentDiaSorin, Inc.
FDA 510(k) clearance K001118 for MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET, Substantially Equivalent on 2000-04-25. Applicant: DiaSorin, Inc.. Device class: 2.
Clearance details
- Applicant
- DiaSorin, Inc.
- Product code
- Code DFC
- Device class
- Class 2
- Regulation
- 21 CFR 866.5600
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Ellicott City, MD, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.