DJB — Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep. Class II
FDA Device Classification
Classification Details
- Product Code
- DJB
- Device Class
- Class II
- Regulation Number
- 862.3450
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K832792 | miles laboratories | AMES TDA SISOMICIN TEST-CONTROL SERUM | September 29, 1983 |
| K831210 | e.i. dupont de nemours and co | GENTAMICIN TEST PACK-ACA | May 25, 1983 |
| K821669 | miles laboratories | AMES TDA GENTAMICIN TEST | December 15, 1982 |
| K812394 | microanalytic research | MRI GENTAMICIN RIA KIT | September 8, 1981 |
| K811844 | diagnostic products | COAT-A-COUNT GENTAMICIN RIA KIT | July 10, 1981 |
| K800537 | alpha gamma laboratory | GAMMA STICK GENTAMICIN RIA KIT | April 24, 1980 |
| K791770 | bio-rad | QUANTIMUNE GENTAMICIN RIA GENTAMICIN | October 17, 1979 |
| K791547 | bio-rad | FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY | October 12, 1979 |
| K782049 | abbott laboratories | BIOASSAY SYSTEM, MS-2 SERUM | August 28, 1979 |
| K790584 | miles laboratories | AMES TDA/GENTGMICIN | June 15, 1979 |
| K790829 | syva | EMIT GENTAMICIN ASSAY | May 15, 1979 |
| K782126 | diagnostic products | RIA KIT, SISOMICIN | February 15, 1979 |
| K781674 | bd becton dickinson vacutainer systems preanalytic | MACRO-VUE TEST, GENTAMICIN | November 15, 1978 |
| K772116 | nichols institute diagnostics | AMINOGLYCOSIDE TEST SYSTEM | April 28, 1978 |
| K780516 | antibodies | GENTAMICIN RIA KIT | April 28, 1978 |
| K780323 | kallestad laboratories | QUANTITOPE 125-I GENTAMICIN RIA KIT | March 17, 1978 |
| K772425 | new england nuclear | RIANEN GENTAMICIN RIA KIT | January 5, 1978 |
| K761157 | diagnostic products | AMINOGLYCOSIDE (125I) RIA KIT | March 1, 1977 |
| K760068 | new england nuclear | KIT, RIA, GENTAMICIN SULF. | July 20, 1976 |