BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY— 510(k) K130268
Substantially EquivalentBecton, Dickinson & CO
FDA 510(k) clearance K130268 for BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY, Substantially Equivalent on 2013-08-23. Applicant: Becton, Dickinson & CO. Device class: 2.
Clearance details
- Applicant
- Becton, Dickinson & CO
- Product code
- Code OUY
- Device class
- Class 2
- Regulation
- 21 CFR 866.3860
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sparks, MD, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.