MACRO-VUE CARD TEST, NETILMICIN
FDA 510(k) clearance K821399 · decided 1982-05-28
Clearance details
- K-number
- K821399
- Device name
- MACRO-VUE CARD TEST, NETILMICIN
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1982-05-11
- Decision date
- 1982-05-28
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- LCE
- Device class
- 2
- Regulation number
- 862.3450
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- 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 |
|---|---|---|
| EMIT NETILMICIN ASSAY (K833715) | Syva Co. | 1983-12-27 |
| AMES TDA NETILMICIN TEST & SERUM (K832088) | Miles Laboratories, Inc. | 1983-10-28 |
| NETILMICIN FLUORESCENT IMMUNOASSAY (K822941) | American Diagnostic Corp. | 1982-10-26 |
| TDX NETILMICIN (K821698) | Abbott Laboratories | 1982-06-22 |
| EMIT AND NETILMICIN ASSAY (K820324) | Syva Co. | 1982-02-23 |
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 |