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

Radioimmunoassay, Netilmicin (I-125)

21 CFR 862.3450 / Clinical Toxicology
FDA source (opens on fda.gov)

LCE is the FDA product code for Radioimmunoassay, Netilmicin (I-125), a class II device type, regulated under 21 CFR 862.3450. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LCE
Device name
Radioimmunoassay, Netilmicin (I-125)
Regulation
21 CFR 862.3450
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
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code LCE

By decision year
6 clearances under product code LCE with a decision year between 1982 and 1983, 1982 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code LCE by decision year
YearClearances
19824
19832

Applicants with the most clearances

Product code LCE
Applicants holding the most 510(k) clearances under product code LCE
ApplicantClearances
Syva Co.2
Abbott Medical1
American Diagnostic Corp.1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Miles Laboratories, 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 LCE.