BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY— 510(k) K081825
Substantially EquivalentBecton, Dickinson & CO
FDA 510(k) clearance K081825 for BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY, Substantially Equivalent on 2008-12-11. Applicant: Becton, Dickinson & CO. Device class: 2.
Clearance details
- Applicant
- Becton, Dickinson & CO
- Product code
- Code LSL
- Device class
- Class 2
- Regulation
- 21 CFR 866.3390
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sparks, MD, US
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Recalls naming K081825
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081825.
Data sourced from openFDA. This site is unofficial and independent of the FDA.