DIRECTIGEN 1-2-3(TM) GROUP A STREP TEST— 510(k) K872493
Substantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalytic
FDA 510(k) clearance K872493 for DIRECTIGEN 1-2-3(TM) GROUP A STREP TEST, Substantially Equivalent on 1987-08-24. 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
- Franklin Lakes, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.