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

Ng1m(A), Antigen, Antiserum, Control

21 CFR 866.5065 / Immunology
FDA source (opens on fda.gov)

DGX is the FDA product code for Ng1m(A), Antigen, Antiserum, Control, a class I device type, regulated under 21 CFR 866.5065. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
DGX
Device name
Ng1m(A), Antigen, Antiserum, Control
Regulation
21 CFR 866.5065
Device class
Class I
Review panel
Immunology
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 DGX

By decision year
1 clearance under product code DGX with a decision year between 1984 and 1984, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DGX by decision year
YearClearances
19841

Applicants with the most clearances

Product code DGX
Applicants holding the most 510(k) clearances under product code DGX
ApplicantClearances
Immucor GTI 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 DGX.