K872628
Substantially EquivalentGONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST
- Applicant
- Ortho Diagnostic Systems, Inc.
- Product code
- LSL
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raritan, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.