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

Bacillus Subtilis, Microbiological Assay, Gentamicin

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

DKD is the FDA product code for Bacillus Subtilis, Microbiological Assay, Gentamicin, a class II device type, regulated under 21 CFR 862.3450. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DKD
Device name
Bacillus Subtilis, Microbiological Assay, 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
2
Ingested recalls
0

Clearances, product code DKD

By decision year
2 clearances under product code DKD with a decision year between 1977 and 1978, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DKD by decision year
YearClearances
19771
19781

Applicants with the most clearances

Product code DKD
Applicants holding the most 510(k) clearances under product code DKD
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic1
Monitor Science Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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