DRI Cocaine Metabolite Assay— 510(k) K211973
Substantially EquivalentMicrogenics Corporation
FDA 510(k) clearance K211973 for DRI Cocaine Metabolite Assay, Substantially Equivalent on 2021-09-24. Applicant: Microgenics Corporation. Device class: 2.
Clearance details
- Applicant
- Microgenics Corporation
- Product code
- Code DIO
- Device class
- Class 2
- Regulation
- 21 CFR 862.3250
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
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More clearances from Microgenics Corporation
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