DIRECTIGEN 1-2-3 GROUP A STREP TEST— 510(k) K951542
Substantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalytic
FDA 510(k) clearance K951542 for DIRECTIGEN 1-2-3 GROUP A STREP TEST, Substantially Equivalent on 1995-10-20. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic.
Clearance details
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Product code
- Code GTZ
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Columbus, NE, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.