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

Hemagglutination Inhibition, Gentamicin

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

DNO is the FDA product code for Hemagglutination Inhibition, 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
DNO
Device name
Hemagglutination Inhibition, 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 DNO

By decision year
1 clearance under product code DNO with a decision year between 1997 and 1997, 1997 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DNO by decision year
YearClearances
19971

Applicants with the most clearances

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