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

Antiserum, Gentamicin

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

DJI is the FDA product code for Antiserum, Gentamicin, a class II device type, regulated under 21 CFR 862.3450. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
DJI
Device name
Antiserum, Gentamicin
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
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code DJI

By decision year
1 clearance under product code DJI with a decision year between 1981 and 1981, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DJI by decision year
YearClearances
19811

Applicants with the most clearances

Product code DJI
Applicants holding the most 510(k) clearances under product code DJI
ApplicantClearances
Kallestad 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 DJI.