510(k) DEN170019
- Device
- Vitamin D 200M Assay for the Topaz System
- Applicant
- Ab Sciex, LLC
- 510(k) number
- DEN170019
- Product code
- PSL
- Decision
- Unknown (DENG)
- Decision date
- 2017-05-18
- Date received
- 2017-03-20
- Regulation
- 862.1840
- Classification name
- 25-Oh-Vitamin D Mass Spectrometry Test System
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- Shilpa Sharma
- Address
- 500 Old Connecticut Path Framingham MA US 01701 01701
FDA Registration Numbers#
- 9610126
- 3003741796
Source Documents#
510(k) summary PDF not indicated by FDA