510(k) K970768— HUMAN LYME IGM WESTERN BLOT KIT
Substantially EquivalentCambridge Diagnostics Ireland, Ltd.
Clearance details
- Applicant
- Cambridge Diagnostics Ireland, Ltd.
- Product code
- Code LSR
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Galway, IE
Data sourced from openFDA. This site is unofficial and independent of the FDA.