DJBClass II

Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.

21 CFR 862.3450 / Clinical Toxicology

DJB is the FDA product code for Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep., a class II device type, regulated under 21 CFR 862.3450. As of 2026-09-10, FDA records hold 19 510(k) clearances under this code, the most recent dated 1983-09-29, and no recalls.

Classification record

Product code: DJB
Device name: Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
Regulation: 21 CFR 862.3450
Device class: Class II
Review panel: Clinical Toxicology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 19
Ingested recalls: 0

Clearances, product code DJB

By decision year

19 clearances under product code DJB with a decision year between 1976 and 1983, 1979 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code DJB by decision year
Year	Clearances
1976	1
1977	1
1978	5
1979	6
1980	1
1981	2
1982	1
1983	2

Applicants with the most clearances

Product code DJB

Applicants holding the most 510(k) clearances under product code DJB
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	3
Miles Laboratories, Inc.	3
Bio-Rad	2
New England Nuclear	2
Abbott Medical	1
Alpha Gamma Laboratory	1
Antibodies, Inc.	1
BD Becton Dickinson Vacutainer Systems Preanalytic	1
E.I. Dupont de Nemours & Co., Inc.	1
Kallestad Laboratories, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code DJB.