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

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

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

DNL is the FDA product code for Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep., a class II device type, regulated under 21 CFR 862.3320. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DNL
Device name
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second 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
8
Ingested recalls
0

Clearances, product code DNL

By decision year
8 clearances under product code DNL with a decision year between 1977 and 1985, 1981 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DNL by decision year
YearClearances
19771
19781
19791
19801
19812
19852

Applicants with the most clearances

Product code DNL
Applicants holding the most 510(k) clearances under product code DNL
ApplicantClearances
American Diagnostic Corp.1
Clinical Assays, Inc.1
E. R. Squibb & Sons, Inc.1
Immuno Assay Corp.1
M Nobird, Inc.1
New England Nuclear1
Nuclear Diagnostics, 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 DNL.