FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEDIA Benzodiazepine Assay
K Number: K190968
·
Decision Dec 9, 2019
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
89
Applicant Total
21
Review Days
241
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Basic Information
- Device Name
- CEDIA Benzodiazepine Assay
- K Number
- K190968
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3170
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microgenics Corporation
- Date Received
- April 12, 2019
- Decision Date
- December 9, 2019
- Product Code
- JXM
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JXM | Enzyme Immunoassay, Benzodiazepine | FDA class 2 | Clinical Toxicology |
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Other Clearances by Microgenics Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K243498 | Alinity c Benzodiazepines Reagent Kit | Dec 11, 2024 | Substantially Equivalent |
| K240670 | DRI Ecstasy Plus Assay | Oct 30, 2024 | Substantially Equivalent |
| K231020 | Alinity c Tricyclic Antidepressants Reagent Kit | Nov 17, 2023 | Substantially Equivalent |
| K231007 | CEDIA Heroin Metabolite (6-AM) Assay | Sep 27, 2023 | Substantially Equivalent |
| K213875 | DRI TM Tricyclics Serum Tox Assay | Dec 21, 2022 | Substantially Equivalent |
| K211973 | DRI Cocaine Metabolite Assay | Sep 24, 2021 | Substantially Equivalent |
| K192943 | CEDIA Heroin Metabolite (6-AM) assay | Dec 16, 2019 | Substantially Equivalent |
| DEN180030 | QMS Plazomicin Immunoassay | Nov 19, 2018 | Unknown |
| K181499 | DRI Cocaine Metabolite Assay | Jul 6, 2018 | Substantially Equivalent |
| K173963 | DRI Benzodiazepine Assay | Feb 21, 2018 | Substantially Equivalent |