LCE · Class II · 21 CFR 862.3450

FDA Product Code LCE: Radioimmunoassay, Netilmicin (i-125)

Leading manufacturers include Syva Co., Bd Becton Dickinson Vacutainer Systems Preanalytic and Abbott Laboratories.

6
Total
6
Cleared
43d
Avg days
1982
Since

FDA 510(k) Cleared Radioimmunoassay, Netilmicin (i-125) Devices (Product Code LCE)

6 devices
1–6 of 6
Cleared Dec 27, 1983
EMIT NETILMICIN ASSAY
K833715
Syva Co.
Toxicology · 67d
Cleared Oct 28, 1983
AMES TDA NETILMICIN TEST & SERUM
K832088
Miles Laboratories, Inc.
Chemistry · 122d
Cleared Oct 26, 1982
NETILMICIN FLUORESCENT IMMUNOASSAY
K822941
American Diagnostic Corp.
Chemistry · 22d
Cleared Jun 22, 1982
TDX NETILMICIN
K821698
Abbott Laboratories
Chemistry · 14d
Cleared May 28, 1982
MACRO-VUE CARD TEST, NETILMICIN
K821399
Bd Becton Dickinson Vacutainer Systems Preanalytic
Toxicology · 17d
Cleared Feb 23, 1982
EMIT AND NETILMICIN ASSAY
K820324
Syva Co.
Toxicology · 18d

About Product Code LCE - Regulatory Context