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

Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin

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

KZT is the FDA product code for Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of 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
KZT
Device name
Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of 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 KZT

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

Applicants with the most clearances

Product code KZT
Applicants holding the most 510(k) clearances under product code KZT
ApplicantClearances
Marion 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 KZT.