Primidone Reagent Test Kit
by Beckman Instruments, Inc. 510(k)
Active
510(k) K820138
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK820138 | Date28 Jan 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DJD
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3680
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The PRIMIDONE REAGENT TEST KIT is an Enzyme Immunoassay device intended to measure primidone, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of primidone overdose and in monitoring levels of primidone to ensure appropriate therapy.
The device is supplied as a test kit and is used in clinical toxicology settings. It is a Class II device with FDA 510(k) clearance K820138, cleared on January 28, 1982. The product code is DJD, and it is manufactured by Beckman Instruments, Inc.
Other devices from Beckman Instruments, Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the PRIMIDONE REAGENT TEST KIT used for?
The PRIMIDONE REAGENT TEST KIT is an Enzyme Immunoassay device designed to measure primidone, an antiepileptic drug, in human specimens. These measurements are used in diagnosing primidone overdose and monitoring drug levels to ensure appropriate therapy.
How is the PRIMIDONE REAGENT TEST KIT supplied?
The device is supplied as a complete test kit for use in clinical toxicology settings. It includes all necessary components for performing the enzyme immunoassay to measure primidone levels in patient specimens.
What is the regulatory status of the PRIMIDONE REAGENT TEST KIT?
The PRIMIDONE REAGENT TEST KIT is a Class II medical device with FDA 510(k) clearance K820138, which was granted on January 28, 1982. It has the product code DJD and is manufactured by Beckman Instruments, Inc.
In what medical specialty is the PRIMIDONE REAGENT TEST KIT used?
This test kit is used in clinical toxicology settings. It helps healthcare professionals monitor primidone levels in patients, diagnose potential overdose situations, and ensure appropriate therapeutic dosing of this antiepileptic medication.