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. Device class: 1.
Clearance details
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Product code
- Code GTZ
- Device class
- Class 1
- Regulation
- 21 CFR 866.3740
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Franklin Lakes, NJ, US
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More clearances from Bd Becton Dickinson Vacutainer Systems Preanalytic
view allData sourced from openFDA. This site is unofficial and independent of the FDA.