Identifiers
- 510(k) Number
- K011393 FDA 510(k)
- FDA Product Code
- DIP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3350 FDA 510(k)
- Regulation Number
- 862.3350 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Randox Phenytoin is an enzyme immunoassay device used for the quantitative determination of diphenylhydantoin in human serum or plasma. This diagnostic tool is classified under clinical toxicology and is intended for use with automated analyzers.
This device is supplied as a liquid ready-to-use reagent kit. It has received FDA 510(k) clearance under regulation number 862.3350.
Frequently asked questions
What is the intended use of the Randox Phenytoin device?
This device is an enzyme immunoassay intended for the quantitative determination of diphenylhydantoin in human serum or plasma samples. It is designed for use in clinical toxicology settings with automated analyzers.
How is the Randox Phenytoin reagent supplied?
The device is supplied as a liquid reagent kit that is ready-to-use. This format is intended to facilitate efficient integration into automated laboratory workflows.
What is the regulatory status of this device?
Randox Phenytoin has received FDA 510(k) clearance under regulation number 862.3350. This indicates the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
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: RANDOX PHENYTOIN (K011393) — FDA 510 (k) | Innolitics, Randox Phenytoin 510 (k) FDA Premarket Notification K011393 RANDOX ..., PHENYTOIN from Randox Laboratories - Labsave, Randox Laboratories Limited - 696569 - 12/06/2024 | FDA, Randox Laboratories, Ltd. FDA 510 (k) Products 2023
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011393 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA 510(k) K011393 24 fields · synced Sep 26, 2026