MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS
FDA 510(k) clearance K963963 · decided 1996-12-12
Clearance details
- K-number
- K963963
- Device name
- MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS
- Applicant
- Becton Dickinson Immunocytometry Systems
- Decision
- Substantially Equivalent
- Date received
- 1996-10-02
- Decision date
- 1996-12-12
- Days to decision
- 71 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 |
|---|---|---|
| BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X ope recall (Z-0570-2008) | BD Biosciences | 2008-03-04 |