ANTI-LEU-12 B CELL REAGENT
FDA 510(k) clearance K851639 · decided 1986-07-02
Clearance details
- K-number
- K851639
- Device name
- ANTI-LEU-12 B CELL REAGENT
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1985-04-19
- Decision date
- 1986-07-02
- Days to decision
- 439 days
- Clearance type
- Traditional
- Product code
- LJD
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Washington, DC, 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 |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |