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

Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.

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

DPB is the FDA product code for Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep., a class II device type, regulated under 21 CFR 862.3320. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DPB
Device name
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal 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
10
Ingested recalls
0

Clearances, product code DPB

By decision year
10 clearances under product code DPB with a decision year between 1976 and 1985, 1979 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DPB by decision year
YearClearances
19761
19772
19793
19823
19851

Applicants with the most clearances

Product code DPB
Applicants holding the most 510(k) clearances under product code DPB
ApplicantClearances
American Diagnostic Corp.1
Cambridge Medical Technology1
Siemens Healthcare Diagnostics Inc.1
Endocrine-Metabolic Center1
Miles Laboratories, Inc.1
Nuclear Medical Laboratories, Inc.1
Pcl-Ria, Inc.1
Radioimmunoassay, Inc.1
Ventrex Laboratories, Inc.1
Wien 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 DPB.