CEDIA Heroin Metabolite (6-AM) assay
FDA 510(k) K192943 · Microgenics Corporation
510(k) numberK192943
Submission
- Device name
- CEDIA Heroin Metabolite (6-AM) assay
- Applicant
- Microgenics Corporation
Fremont, CA, US - Received
- October 18, 2019
- Decision date
- December 16, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
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| K231007 | CEDIA Heroin Metabolite (6-AM) AssayDJG · Traditional | 09/27/2023SE |
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| K190968 | CEDIA Benzodiazepine AssayJXM · Traditional | 12/09/2019SE |
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| K173963 | DRI Benzodiazepine AssayJXM · Traditional | 02/21/2018SE |
| K173195 | DRI Hydrocodone AssayDJG · Traditional | 02/13/2018SE |
Questions and answers
When was CEDIA Heroin Metabolite (6-AM) assay cleared by the FDA?
CEDIA Heroin Metabolite (6-AM) assay (K192943) received a 510(k) decision of Substantially Equivalent on December 16, 2019, 59 days after the submission was received.
What is the product code of K192943?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.