510(k) K894609— MARDX LYME DISEASE IFA (IGM) TEST SYSTEM
Substantially EquivalentMardx, Inc.
Clearance details
- Applicant
- Mardx, Inc.
- Product code
- Code LSR
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scotch Plains, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.