BD TRITEST CD3/CD4/CD45, MODEL 340383
FDA 510(k) clearance K071143 · decided 2007-06-06
Clearance details
- K-number
- K071143
- Device name
- BD TRITEST CD3/CD4/CD45, MODEL 340383
- Applicant
- Bd Biosciences
- Decision
- Substantially Equivalent
- Date received
- 2007-04-24
- Decision date
- 2007-06-06
- Days to decision
- 43 days
- Clearance type
- Special
- 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 |
|---|---|---|
| BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains recall (Z-2378-2016) | Becton, Dickinson and Company, BD Biosciences | 2016-08-09 |