DRI Ecstasy Plus Assay
FDA 510(k) K240670 · Microgenics Corporation
510(k) numberK240670
Submission
- Device name
- DRI Ecstasy Plus Assay
- Applicant
- Microgenics Corporation
Fremont, CA, US - Received
- March 11, 2024
- Decision date
- October 30, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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| 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 |
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Questions and answers
When was DRI Ecstasy Plus Assay cleared by the FDA?
DRI Ecstasy Plus Assay (K240670) received a 510(k) decision of Substantially Equivalent on October 30, 2024, 233 days after the submission was received.
What is the product code of K240670?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.