K854615
Substantially EquivalentMONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES
- Applicant
- Serono Diagnostics, Inc.
- Product code
- LKI
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bramtree, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.