DIRECTIGEN MENINGITIS COMBO TEST KIT— 510(k) K915330
Substantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalytic
FDA 510(k) clearance K915330 for DIRECTIGEN MENINGITIS COMBO TEST KIT, Substantially Equivalent on 1992-03-23. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic.
Clearance details
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Product code
- Code GTJ
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Franklin Lakes, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.