BD FACS 7-COLOR SETUP BEADS
FDA 510(k) clearance K040026 · decided 2004-09-10
Clearance details
- K-number
- K040026
- Device name
- BD FACS 7-COLOR SETUP BEADS
- Applicant
- Becton Dickinson Immunocytometry Systems
- Decision
- Substantially Equivalent
- Date received
- 2004-01-07
- Decision date
- 2004-09-10
- Days to decision
- 247 days
- Clearance type
- Traditional
- Product code
- GKZ
- 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
| Record | Firm | Date |
|---|---|---|
| REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow recall (Z-2078-2025) | Becton, Dickinson and Company, BD Bio Sciences | 2025-07-03 |
| REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for f recall (Z-2079-2025) | Becton, Dickinson and Company, BD Bio Sciences | 2025-07-03 |
| BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Bead recall (Z-2397-2012) | BD Biosciences, Systems & Reagents | 2012-09-17 |