Diazyme Lipoprotein (a) Assay— 510(k) K180074
Substantially EquivalentDiazyme Laboratories, Inc.
FDA 510(k) clearance K180074 for Diazyme Lipoprotein (a) Assay, Substantially Equivalent on 2018-03-22. Applicant: Diazyme Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Diazyme Laboratories, 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
- Traditional
- Location
- Poway, CA, US
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