DIRECTIGEN COMBO MENINGITIS TEST— 510(k) K860768
Substantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalytic
FDA 510(k) clearance K860768 for DIRECTIGEN COMBO MENINGITIS TEST, Substantially Equivalent on 1986-05-13. 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
- Paramus, NJ, US
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More clearances from Bd Becton Dickinson Vacutainer Systems Preanalytic
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