VERDICT -II TCA, VERDICT-II MTD
FDA 510(k) clearance K011545 · decided 2001-06-08
Clearance details
- K-number
- K011545
- Device name
- VERDICT -II TCA, VERDICT-II MTD
- Applicant
- Medtox Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-05-18
- Decision date
- 2001-06-08
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- LFG
- Device class
- 2
- Regulation number
- 862.3910
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Burlington, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.