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

Plasminogen, Antigen, Antiserum, Control

21 CFR 866.5715 / Immunology
FDA source (opens on fda.gov)

DDX is the FDA product code for Plasminogen, Antigen, Antiserum, Control, a class I device type, regulated under 21 CFR 866.5715. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DDX
Device name
Plasminogen, Antigen, Antiserum, Control
Regulation
21 CFR 866.5715
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
10
Ingested recalls
0

Clearances, product code DDX

By decision year
10 clearances under product code DDX with a decision year between 1978 and 1994, 1978 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DDX by decision year
YearClearances
19782
19812
19831
19851
19862
19891
19941

Applicants with the most clearances

Product code DDX
Applicants holding the most 510(k) clearances under product code DDX
ApplicantClearances
Behring Diagnostics, Inc.1
Dade, Baxter Travenol Diagnostics, Inc.1
E.I. Dupont de Nemours & Co., Inc.1
Helena Laboratories, Corp.1
Hyland Therapeutic Div., Travenol Laboratories1
Instrumentation Laboratory Co.1
Kabivitrum, Inc.1
The Binding Site1
Warner-Lambert Co.1
Wellcome Diagnostics1

Companies listing this code with FDA

Companies whose registered establishments list this code