K243343
- 510(k) number
- K243343
- Device name
- BD CTGCTV2
- Applicant
- Bd Integrated Diagnostic Solutions/Becton, MD · US
- Product code
- QEP — Nucleic Acid Detection System For Non-Viral Microorg
- Decision date
- 2025-04-22
- Date received
- 2024-10-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K243343.pdf
Official FDA record: K243343
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.