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
DJKClass I

Digitoxin Control Serum, Ria

21 CFR 862.3280 / Clinical Toxicology
FDA source (opens on fda.gov)

DJK is the FDA product code for Digitoxin Control Serum, Ria, a class I device type, regulated under 21 CFR 862.3280. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
DJK
Device name
Digitoxin Control Serum, Ria
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code DJK

By decision year
1 clearance under product code DJK with a decision year between 1978 and 1978, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DJK by decision year
YearClearances
19781

Applicants with the most clearances

Product code DJK
Applicants holding the most 510(k) clearances under product code DJK
ApplicantClearances
Siemens Healthcare Diagnostics 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 DJK.