LDO · Class II · 21 CFR 862.3900

FDA Product Code LDO: Enzymatic Radiochemical Assay, Tobramycin

Leading manufacturers include Ortho-Clinical Diagnostics, Inc. and Syva Co..

3
Total
3
Cleared
65d
Avg days
1983
Since

FDA 510(k) Cleared Enzymatic Radiochemical Assay, Tobramycin Devices (Product Code LDO)

3 devices
1–3 of 3
Cleared Feb 07, 2005
VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III
K043384
Ortho-Clinical Diagnostics, Inc.
Chemistry · 60d
Cleared Aug 08, 1983
EMIT ASSAY AND TOBRAMYCIN
K832055
Syva Co.
Chemistry · 42d

About Product Code LDO - Regulatory Context