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

Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.

21 CFR 862.3300 / Clinical Toxicology
FDA source (opens on fda.gov)

DND is the FDA product code for Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep., a class II device type, regulated under 21 CFR 862.3300. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
DND
Device name
Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.
Regulation
21 CFR 862.3300
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 DND

By decision year
1 clearance under product code DND with a decision year between 1976 and 1976, 1976 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DND by decision year
YearClearances
19761

Applicants with the most clearances

Product code DND
Applicants holding the most 510(k) clearances under product code DND
ApplicantClearances
Smithkline Diagnostics, 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 DND.