BD CTGCTV2
FDA 510(k) clearance K243343 · decided 2025-04-22
Clearance details
- K-number
- K243343
- Device name
- BD CTGCTV2
- Applicant
- Bd Integrated Diagnostic Solutions/Becton,
- Decision
- Substantially Equivalent
- Date received
- 2024-10-25
- Decision date
- 2025-04-22
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- QEP
- Device class
- 2
- Regulation number
- 866.3393
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sparks, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.