Ames TDA TM Primidone Test
by Miles Laboratories, Inc. 510(k)
Active
510(k) K811007
Overview
The Ames TDA TM Primidone Test is a fluorescent immunoassay for primidone, classified under Clinical Toxicology. It is a diagnostic device used to detect primidone levels in patient samples.
The device received FDA 510(k) clearance (K811007) on April 29, 1981, as substantially equivalent to a predicate device. It is manufactured by Miles Laboratories, Inc. and is intended for use in clinical laboratory settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK811007 | Date29 Apr 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- LFT
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3680
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Miles Laboratories, Inc.
Questions
What is the Ames TDA TM Primidone Test used for?
The Ames TDA TM Primidone Test is a diagnostic device designed for use in clinical laboratory settings. It is a fluorescent immunoassay intended to detect primidone levels in patient samples.
How was the device cleared for use?
The device received FDA 510(k) clearance (K811007) on April 29, 1981, as substantially equivalent to a predicate device.
What is the device's classification and specialty?
The device is classified under Clinical Toxicology and is a fluorescent immunoassay for primidone.
Who manufactures the Ames TDA TM Primidone Test?
The device is manufactured by Miles Laboratories, Inc.