MACRO-VUE TEST, GENTAMICIN
FDA 510(k) clearance K781674 · decided 1978-11-15
Clearance details
- K-number
- K781674
- Device name
- MACRO-VUE TEST, GENTAMICIN
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1978-10-03
- Decision date
- 1978-11-15
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- DJB
- 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 |
|---|---|---|
| AMES TDA SISOMICIN TEST-CONTROL SERUM (K832792) | Miles Laboratories, Inc. | 1983-09-29 |
| GENTAMICIN TEST PACK-ACA (K831210) | E.I. Dupont DE Nemours & Co., Inc. | 1983-05-25 |
| AMES TDA GENTAMICIN TEST (K821669) | Miles Laboratories, Inc. | 1982-12-15 |
| MRI GENTAMICIN RIA KIT (K812394) | Microanalytic Research, Inc. | 1981-09-08 |
| COAT-A-COUNT GENTAMICIN RIA KIT (K811844) | Diagnostic Products Corp. | 1981-07-10 |
| GAMMA STICK GENTAMICIN RIA KIT (K800537) | Alpha Gamma Laboratory | 1980-04-24 |
| QUANTIMUNE GENTAMICIN RIA GENTAMICIN (K791770) | Bio-Rad | 1979-10-17 |
| FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY (K791547) | Bio-Rad | 1979-10-12 |
| BIOASSAY SYSTEM, MS-2 SERUM (K782049) | Abbott Laboratories | 1979-08-28 |
| AMES TDA/GENTGMICIN (K790584) | Miles Laboratories, Inc. | 1979-06-15 |
| EMIT GENTAMICIN ASSAY (K790829) | Syva Co. | 1979-05-15 |
| RIA KIT, SISOMICIN (K782126) | Diagnostic Products Corp. | 1979-02-15 |
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 |