BBL DIRECTIGEN MENINGITIS TEST KIT
FDA 510(k) clearance K821266 · decided 1982-06-01
Clearance details
- K-number
- K821266
- Device name
- BBL DIRECTIGEN MENINGITIS TEST KIT
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1982-05-03
- Decision date
- 1982-06-01
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- GRP
- Device class
- 2
- Regulation number
- 866.3300
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BACTIGEN(R) H. INFLUENZAE TYPE B (K884967) | Armkel, LLC | 1989-02-07 |
| IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES (K854490) | American Micro Scan | 1985-12-27 |
| H-FLU B ELISA TEST (K831525) | Seragen Diagnostics, Inc. | 1983-09-29 |
| H. INFLUENZA B ANTISERA FOR CIE (K823348) | Diagnostica, Inc. | 1982-12-28 |
| HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM (K820192) | Hyland Therapeutic Div., Travenol Laboratories | 1982-03-11 |
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 |