Lipoprotein (A) SPQ III Antibody Reagent Set
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K993669 FDA 510(k)
- FDA Product Code
- DFC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5600 FDA 510(k)
- Regulation Number
- 866.5600 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Lipoprotein (A) SPQ III Antibody Reagent Set is an in vitro diagnostic reagent set classified as a lipoprotein, low-density antigen, antiserum, and control. It is designed for the quantitative measurement of human lipoprotein(a) in serum using immunoprecipitin analysis on a turbidimetric clinical analyzer.
This reagent set is intended for single-use in clinical laboratory settings and has received FDA 510(k) clearance under Special Controls. It is supplied as a diagnostic kit for use with appropriate analyzers and adheres to regulatory requirements for in vitro diagnostic devices, including product code DFC under regulation number 866.5600.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Lipoprotein (A) Spq Iii Antibody Reagent Set, FDA Browser - Cleared 510 (K) - LIPOPROTEIN (A) SPQ III ANTIBODY ..., K994110 - Lipoprotein (A) Spq Iii Antibody Reagent Set, Lipoprotein (A) Spq Iii Antibody Reagent Set - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K993669 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA 510(k) K993669 24 fields · synced Sep 19, 2026