510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LDOClass II

Enzymatic Radiochemical Assay, Tobramycin

21 CFR 862.3900 / Clinical Toxicology
FDA source (opens on fda.gov)

LDO is the FDA product code for Enzymatic Radiochemical Assay, Tobramycin, a class II device type, regulated under 21 CFR 862.3900. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LDO
Device name
Enzymatic Radiochemical Assay, Tobramycin
Regulation
21 CFR 862.3900
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code LDO

By decision year
3 clearances under product code LDO with a decision year between 1983 and 2005, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LDO by decision year
YearClearances
19831
19841
20051

Applicants with the most clearances

Product code LDO
Applicants holding the most 510(k) clearances under product code LDO
ApplicantClearances
Cardiac Resucitator Corp.1
Ortho-Clinical Diagnostics, Inc.1
Syva Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code