MULTIWELL CULTURE PLATE INSERTS
FDA 510(k) clearance K890542 · decided 1989-02-14
Clearance details
- K-number
- K890542
- Device name
- MULTIWELL CULTURE PLATE INSERTS
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1989-02-03
- Decision date
- 1989-02-14
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- KIZ
- Device class
- 1
- Regulation number
- 864.2240
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Franklin Lakes, NJ, 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 |
|---|---|---|
| TISSUE CULTURE DISHES (K873891) | Nunc, Inc. | 1987-11-25 |
| TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES (K871483) | Isratech Marketing Corp. | 1987-04-29 |
| CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE (K854724) | Lifetrac, Inc. | 1985-12-13 |
| CORNING CELL WELLS-MULTIPLE WELL PLATES (K853634) | Corning Medical & Scientific | 1985-09-16 |
| REMOVAWELL TISSUE CULTURE PLATE W/LID (K821687) | Dynatech Corp. | 1982-06-24 |
| 120 WELL HISTO-PLATE (K790958) | Dynatech Laboratories, Inc. | 1979-06-28 |
| PRESSURIZER, EXETER CEMENT (K781792) | Howmedica Corp. | 1979-02-08 |
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 |