510(k) K912371— BIOMERIEUX RSV DIRECT IF KIT
Substantially EquivalentVitek Systems, Inc.
Clearance details
- Applicant
- Vitek Systems, Inc.
- Product code
- Code LKT
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hazelwood, MI, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.