DJB — Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep. Class II
FDA product code DJB covers "Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.", a Class II medical device regulated under 21 CFR 862.3450. Submissions are reviewed by the Clinical Toxicology panel. At least 19 recent 510(k) clearances have been granted under this product code.
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 |
| K780516 | antibodies | GENTAMICIN RIA KIT | April 28, 1978 |
| K772116 | nichols institute diagnostics | AMINOGLYCOSIDE TEST SYSTEM | 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 |