Vitamin D 200M Assay for the Topaz System
FDA 510(k) clearance DEN170019 · decided 2017-05-18
Clearance details
- K-number
- DEN170019
- Device name
- Vitamin D 200M Assay for the Topaz System
- Applicant
- Ab Sciex, LLC
- Decision
- Unknown
- Date received
- 2017-03-20
- Decision date
- 2017-05-18
- Days to decision
- 59 days
- Clearance type
- Post-NSE
- Product code
- PSL
- Device class
- 2
- Regulation number
- 862.1840
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Framingham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.