DJB · Class II · 21 CFR 862.3450

FDA Product Code DJB: Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep.

Leading manufacturers include Diagnostic Products Corp., Miles Laboratories, Inc. and Bio-Rad.

19
Total
19
Cleared
66d
Avg days
1976
Since

FDA 510(k) Cleared Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. Devices (Product Code DJB)

19 devices
1–19 of 19
Cleared Sep 29, 1983
AMES TDA SISOMICIN TEST-CONTROL SERUM
K832792
Miles Laboratories, Inc.
Chemistry · 44d
Cleared May 25, 1983
GENTAMICIN TEST PACK-ACA
K831210
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 41d
Cleared Dec 15, 1982
AMES TDA GENTAMICIN TEST
K821669
Miles Laboratories, Inc.
Chemistry · 191d
Cleared Jul 10, 1981
COAT-A-COUNT GENTAMICIN RIA KIT
K811844
Diagnostic Products Corp.
Chemistry · 9d
Cleared Oct 17, 1979
QUANTIMUNE GENTAMICIN RIA GENTAMICIN
K791770
Bio-Rad
Toxicology · 40d
Cleared Oct 12, 1979
FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY
K791547
Bio-Rad
Toxicology · 63d
Cleared Aug 28, 1979
BIOASSAY SYSTEM, MS-2 SERUM
K782049
Abbott Laboratories
Microbiology · 263d
Cleared Jun 15, 1979
AMES TDA/GENTGMICIN
K790584
Miles Laboratories, Inc.
Toxicology · 80d
Cleared May 15, 1979
EMIT GENTAMICIN ASSAY
K790829
Syva Co.
Toxicology · 15d
Cleared Feb 15, 1979
RIA KIT, SISOMICIN
K782126
Diagnostic Products Corp.
Toxicology · 50d
Cleared Nov 15, 1978
MACRO-VUE TEST, GENTAMICIN
K781674
Bd Becton Dickinson Vacutainer Systems Preanalytic
Toxicology · 43d
Cleared Mar 01, 1977
AMINOGLYCOSIDE (125I) RIA KIT
K761157
Diagnostic Products Corp.
Immunology · 92d

About Product Code DJB - Regulatory Context