Dri Oxycodone Assay
FDA 510(k) K040411 · Microgenics Corp.
510(k) numberK040411
Submission
- Device name
- Dri Oxycodone Assay
- Applicant
- Microgenics Corp.
Fremont Blvd., CA, US - Received
- February 18, 2004
- Decision date
- May 27, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LAS – Drug Specific Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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| K231007 | CEDIA Heroin Metabolite (6-AM) AssayDJG · Traditional | 09/27/2023SE |
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| K211973 | DRI Cocaine Metabolite AssayDIO · Traditional | 09/24/2021SE |
| K192943 | CEDIA Heroin Metabolite (6-AM) assayDJG · Traditional | 12/16/2019SE |
| K190968 | CEDIA Benzodiazepine AssayJXM · Traditional | 12/09/2019SE |
| K181499 | DRI Cocaine Metabolite AssayDIO · Traditional | 07/06/2018SE |
| K173963 | DRI Benzodiazepine AssayJXM · Traditional | 02/21/2018SE |
Questions and answers
When was Dri Oxycodone Assay cleared by the FDA?
Dri Oxycodone Assay (K040411) received a 510(k) decision of Substantially Equivalent on May 27, 2004, 99 days after the submission was received.
What is the product code of K040411?
The FDA product code is LAS – Drug Specific Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.