Dri Oxycodone Assay
510(k) K040411
Dri Oxycodone Assay is a Class I device made by Microgenics Corporation, cleared under FDA 510(k) K040411 on 27 May 2004, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK040411 | Date27 May 2004 | StatusActive |
Official records
- FDA 510(k) database K040411
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LAS
- FDA applicant
- Microgenics Corp.
- Device class
- Class I
- Regulation
- 21 CFR Part 862.3280
- Advisory committee
- Clinical Toxicology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K040411
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| DRI Oxycodone Assay 10015632 | 10015632 | 00884883011625 | On the market | |
| DRI Oxycodone Assay 100248 | 100248 | 00884883003477 | On the market | |
| DRI Oxycodone Assay 100249 | 100249 | 00884883002968 | On the market | |
| DRI Oxycodone Assay for Synchron Systems 10012653 | 10012653 | 00884883005822 | On the market | |
| OXY DRI Oxycodone 09026916 190 | 09026916 190 | 07613336190791 | On the market | |
| OXY Oxycodone 08321248 190 | 08321248 190 | 07613336154045 | On the market |
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