BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY— 510(k) K140446
Substantially EquivalentBecton, Dickinson & CO
FDA 510(k) clearance K140446 for BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY, Substantially Equivalent on 2014-05-20. Applicant: Becton, Dickinson & CO. Device class: 1.
Clearance details
- Applicant
- Becton, Dickinson & CO
- Product code
- Code MKZ
- Device class
- Class 1
- Regulation
- 21 CFR 866.3120
- Advisory panel
- Microbiology
- 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.