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

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

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

DON is the FDA product code for Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep., a class II device type, regulated under 21 CFR 862.3320. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DON
Device name
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase 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
17
Ingested recalls
0

Clearances, product code DON

By decision year
17 clearances under product code DON with a decision year between 1976 and 1990, 1978 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code DON by decision year
YearClearances
19761
19773
19784
19791
19801
19811
19822
19831
19841
19881
19901

Applicants with the most clearances

Product code DON
Applicants holding the most 510(k) clearances under product code DON
ApplicantClearances
Burroughs Wellcome Co.2
Ciba Corning Diagnostics Corp.2
Abbott Medical1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Bio-Rad1
Biological & Diagnostic Products1
Corning Medical & Scientific1
Damon Corp.1
E. R. Squibb & Sons, Inc.1
Icl Scientific1

Companies listing this code with FDA

Companies whose registered establishments list this code

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