FDA Product Code DJB: Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep.
Leading manufacturers include Diagnostic Products Corp., Miles Laboratories, Inc. and New England Nuclear.
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
Cleared
Sep 29, 1983
AMES TDA SISOMICIN TEST-CONTROL SERUM
Miles Laboratories, Inc.
Chemistry
44d
Cleared
May 25, 1983
GENTAMICIN TEST PACK-ACA
E.I. Dupont DE Nemours & Co., Inc.
Toxicology
41d
Cleared
Dec 15, 1982
AMES TDA GENTAMICIN TEST
Miles Laboratories, Inc.
Chemistry
191d
Cleared
Jul 10, 1981
COAT-A-COUNT GENTAMICIN RIA KIT
Diagnostic Products Corp.
Chemistry
9d
Cleared
Oct 17, 1979
QUANTIMUNE GENTAMICIN RIA GENTAMICIN
Bio-Rad
Toxicology
40d
Cleared
Oct 12, 1979
FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY
Bio-Rad
Toxicology
63d
Cleared
Aug 28, 1979
BIOASSAY SYSTEM, MS-2 SERUM
Abbott Laboratories
Microbiology
263d
Cleared
Jun 15, 1979
AMES TDA/GENTGMICIN
Miles Laboratories, Inc.
Toxicology
80d
Cleared
May 15, 1979
EMIT GENTAMICIN ASSAY
Syva Co.
Toxicology
15d
Cleared
Feb 15, 1979
RIA KIT, SISOMICIN
Diagnostic Products Corp.
Toxicology
50d
Cleared
Nov 15, 1978
MACRO-VUE TEST, GENTAMICIN
Bd Becton Dickinson Vacutainer Systems Preanalytic
Toxicology
43d
Cleared
Apr 28, 1978
AMINOGLYCOSIDE TEST SYSTEM
Nichols Institute Diagnostics
Immunology
172d
Cleared
Mar 17, 1978
QUANTITOPE 125-I GENTAMICIN RIA KIT
Kallestad Laboratories, Inc.
Immunology
18d
Cleared
Jan 05, 1978
RIANEN GENTAMICIN RIA KIT
New England Nuclear
Immunology
7d
Cleared
Mar 01, 1977
AMINOGLYCOSIDE (125I) RIA KIT
Diagnostic Products Corp.
Immunology
92d
Cleared
Jul 20, 1976
KIT, RIA, GENTAMICIN SULF.
New England Nuclear
Toxicology
34d