Analysis System, Prep Sample
by E.I. Dupont DE Nemours & Co., Inc.
510(k) K781941
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781941 | Date3 Jan 1979 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DOZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3350
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
This device is a sample preparation analysis system intended for use in clinical toxicology. It is designed to process and prepare samples for liquid chromatography analysis, specifically for the measurement of diphenylhydantoin levels.
The device is regulated under FDA product code DOZ and was authorized through the 510(k) premarket notification process. It is classified as a Class II medical device and is intended for use in clinical toxicology settings. The system is designed for single-use or limited reuse as specified by the manufacturer's guidelines.
Other devices from E.I. Dupont DE Nemours & Co., Inc.
Questions
AI-generated answers, 6 Oct 2026
What is the intended use of the Prep Sample Analysis System?
The system is intended for use in clinical toxicology settings to prepare samples for liquid chromatography analysis, specifically for measuring diphenylhydantoin levels.
Is the Prep Sample Analysis System for single-use or reuse?
The system is designed for single-use or limited reuse as specified by the manufacturer's guidelines.
What type of medical device is the Prep Sample Analysis System classified as?
The system is classified as a Class II medical device.