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

Antiserum, Digoxin

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

DKA is the FDA product code for Antiserum, Digoxin, a class II device type, regulated under 21 CFR 862.3320. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
DKA
Device name
Antiserum, Digoxin
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
3
Ingested recalls
1

Clearances, product code DKA

By decision year
3 clearances under product code DKA with a decision year between 1978 and 1994, 1978 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DKA by decision year
YearClearances
19782
19941

Applicants with the most clearances

Product code DKA
Applicants holding the most 510(k) clearances under product code DKA
ApplicantClearances
Baxter Diagnostics, Inc.1
Clinical Bioresearch1
Pcl-Ria, 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 DKA.