Product code DJB— Clinical Toxicology
AMES TDA GENTAMICIN TEST
- Classification name
- Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
- Device class
- Class 2
- Regulation
- 21 CFR 862.3450
- Advisory panel
- Clinical Toxicology
- Total cleared
- 19
- First cleared
- Most recent
Market context for product code DJB
FDA has cleared devices under product code DJB between 1976 and 1983, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1983
- 1982
- 1981
- 1980
- 1979
- 1978
- 1977
- 1976
Top applicants under product code DJB
Recent clearances under product code DJB
- K832792 — AMES TDA SISOMICIN TEST-CONTROL SERUM
- K831210 — GENTAMICIN TEST PACK-ACA
- K821669 — AMES TDA GENTAMICIN TEST
- K812394 — MRI GENTAMICIN RIA KIT
- K811844 — COAT-A-COUNT GENTAMICIN RIA KIT
- K800537 — GAMMA STICK GENTAMICIN RIA KIT
- K791770 — QUANTIMUNE GENTAMICIN RIA GENTAMICIN
- K791547 — FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY
- K782049 — BIOASSAY SYSTEM, MS-2 SERUM
- K790584 — AMES TDA/GENTGMICIN
- K790829 — EMIT GENTAMICIN ASSAY
- K782126 — RIA KIT, SISOMICIN
- K781674 — MACRO-VUE TEST, GENTAMICIN
- K772116 — AMINOGLYCOSIDE TEST SYSTEM
- K780516 — GENTAMICIN RIA KIT
- K780323 — QUANTITOPE 125-I GENTAMICIN RIA KIT
- K772425 — RIANEN GENTAMICIN RIA KIT
- K761157 — AMINOGLYCOSIDE (125I) RIA KIT
- K760068 — KIT, RIA, GENTAMICIN SULF.
Data sourced from openFDA. This site is unofficial and independent of the FDA.