Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit— 510(k) K160819
Substantially EquivalentThe Binding Site Group , Ltd.
FDA 510(k) clearance K160819 for Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit, Substantially Equivalent on 2016-06-16. Applicant: The Binding Site Group , Ltd..
Clearance details
- Applicant
- The Binding Site Group , Ltd.
- Product code
- Code OPX
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edgbaston, GB
Data sourced from openFDA. This site is unofficial and independent of the FDA.