LDN · Class II · 21 CFR 862.3035

FDA Product Code LDN: Enzymatic Radiochemical Assay, Amikacin

Leading manufacturers include Syva Co. and Beckman Instruments, Inc..

3
Total
3
Cleared
43d
Avg days
1982
Since

FDA 510(k) Cleared Enzymatic Radiochemical Assay, Amikacin Devices (Product Code LDN)

3 devices
1–3 of 3
Cleared Apr 02, 1984
AMIKACIN REAGENT TEST KIT
K840647
Beckman Instruments, Inc.
Immunology · 47d
Cleared Dec 08, 1983
MODIFICATION OF EMIT AND AMIKACIN ASSAY
K833546
Syva Co.
Toxicology · 55d
Cleared Mar 15, 1982
EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO
K820440
Syva Co.
Toxicology · 26d

About Product Code LDN - Regulatory Context