510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DORClass II

Radioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep.

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

DOR is the FDA product code for Radioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep., a class II device type, regulated under 21 CFR 862.3320. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
DOR
Device name
Radioimmunoassay, Digoxin (3-H), Bovine 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
1
Ingested recalls
0

Clearances, product code DOR

By decision year
1 clearance under product code DOR with a decision year between 1980 and 1980, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DOR by decision year
YearClearances
19801

Applicants with the most clearances

Product code DOR
Applicants holding the most 510(k) clearances under product code DOR
ApplicantClearances
Stanco Medical, 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 DOR.