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
DGKClass II

Igg, Fitc, Antigen, Antiserum, Control

21 CFR 866.5510 / Immunology
FDA source (opens on fda.gov)

DGK is the FDA product code for Igg, Fitc, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5510. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
DGK
Device name
Igg, Fitc, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
1

Clearances, product code DGK

By decision year
2 clearances under product code DGK with a decision year between 1983 and 1983, 1983 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DGK by decision year
YearClearances
19832

Applicants with the most clearances

Product code DGK
Applicants holding the most 510(k) clearances under product code DGK
ApplicantClearances
Dako Corp.1
Intl. Diagnostic Technology1

Companies listing this code with FDA

Companies whose registered establishments list this code