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

Enzymatic Radiochemical Assay, Amikacin

21 CFR 862.3035 / Clinical Toxicology
FDA source (opens on fda.gov)

LDN is the FDA product code for Enzymatic Radiochemical Assay, Amikacin, a class II device type, regulated under 21 CFR 862.3035. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LDN
Device name
Enzymatic Radiochemical Assay, Amikacin
Regulation
21 CFR 862.3035
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 LDN

By decision year
3 clearances under product code LDN with a decision year between 1982 and 1984, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LDN by decision year
YearClearances
19821
19831
19841

Applicants with the most clearances

Product code LDN
Applicants holding the most 510(k) clearances under product code LDN
ApplicantClearances
Syva Co.2
Beckman Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LDN.