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

Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.

21 CFR 862.3320 / Clinical Toxicology
FDA source (opens on fda.gov)

DNJ is the FDA product code for Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep., a class II device type, regulated under 21 CFR 862.3320. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DNJ
Device name
Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.
Regulation
21 CFR 862.3320
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 DNJ

By decision year
2 clearances under product code DNJ with a decision year between 1977 and 1977, 1977 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DNJ by decision year
YearClearances
19772

Applicants with the most clearances

Product code DNJ
Applicants holding the most 510(k) clearances under product code DNJ
ApplicantClearances
Antibodies, Inc.1
G.D. Searle and Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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