Radias B12 Enzyme Immunoassay
FDA 510(k)Class II (US FDA 510(k))
by Bio-Rad
Identifiers
- 510(k) Number
- K933315 FDA 510(k)
- FDA Product Code
- CDD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1810 FDA 510(k)
- Regulation Number
- 862.1810 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The RADIAS B12 ENZYME IMMUNOASSAY is a radioassay device for measuring vitamin B12, classified under the medical specialty of Clinical Chemistry. It is a substantially equivalent device cleared via the traditional 510(k) pathway.
The device is supplied by Bio-Rad and has FDA 510(k) clearance under K933315. It is intended for use in clinical laboratory settings and is regulated as a Class II medical device under regulation number 862.1810.
Frequently asked questions
What is the RADIAS B12 ENZYME IMMUNOASSAY used for?
The RADIAS B12 ENZYME IMMUNOASSAY is used for measuring vitamin B12 levels in clinical laboratory settings, as it is a radioassay device classified under Clinical Chemistry for this specific diagnostic purpose.
How is the RADIAS B12 ENZYME IMMUNOASSAY supplied and is it sterile or single-use?
The device is supplied by Bio-Rad as a radioassay test system; however, the provided data does not specify sterility, single-use, or reusable status, so no conclusion can be drawn about its supply format or sterility from the given information.
What regulatory pathway was used to clear the RADIAS B12 ENZYME IMMUNOASSAY?
The RADIAS B12 ENZYME IMMUNOASSAY was cleared via the traditional 510(k) pathway, as indicated by its FDA 510(k) authorization under K933315 and its classification as a substantially equivalent device.
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: RADIAS B12 ENZYME IMMUNOASSAY (K933315) — FDA 510 (k) | Innolitics, Radias B12 Enzyme Immunoassay 510 (k) K933315 - FDA.report, EQAS Specialty Immunoassay Program #12015696 | Bio-Rad, RADIAS B12 ENZYME IMMUNOASSAY (K933315) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K933315 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio-Rad
Sources (1)
- FDA 510(k) K933315 24 fields · synced Sep 26, 2026