TruDiagnosis System
FDA 510(k) clearance K183530 · decided 2019-05-24
Clearance details
- K-number
- K183530
- Device name
- TruDiagnosis System
- Applicant
- Akonni Biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-12-19
- Decision date
- 2019-05-24
- Days to decision
- 156 days
- Clearance type
- Traditional
- Product code
- ODW
- Device class
- 2
- Regulation number
- 862.3360
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Frederick, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.