BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit
FDA 510(k) clearance K150815 · decided 2015-12-17
Clearance details
- K-number
- K150815
- Device name
- BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit
- Applicant
- Becton, Dickinson and Company
- Decision
- Substantially Equivalent
- Date received
- 2015-03-27
- Decision date
- 2015-12-17
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- PMG
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BD ONCLARITY HPV ASSAY (P160037/S022) | Becton, Dickinson and Company | 2025-08-25 |
| BD Onclarity HPV Assay (P160037/S023) | Becton, Dickinson and Company | 2025-07-02 |
| Onclarity HPV Assay (P160037/S021) | Becton, Dickinson and Company | 2025-03-12 |
| BD Onclarity HPV Assay (P160037/S020) | Becton, Dickinson and Company | 2024-11-05 |
| BD Onclarity HPV Assay (P160037/S017) | Becton, Dickinson and Company | 2024-05-14 |
| BD Onclarity HPV Assay (P160037/S019) | Becton, Dickinson and Company | 2024-04-18 |
| BD Onclarity HPV Assay (P160037/S018) | Becton, Dickinson and Company | 2023-11-20 |
| BD Onclarity HPV (P160037/S016) | Becton, Dickinson and Company | 2023-11-15 |