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

Transferrin, Fitc, Antigen, Antiserum, Control

21 CFR 866.5880 / Immunology
FDA source (opens on fda.gov)

DDI is the FDA product code for Transferrin, Fitc, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5880. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DDI
Device name
Transferrin, Fitc, Antigen, Antiserum, Control
Regulation
21 CFR 866.5880
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
0

Clearances, product code DDI

By decision year
2 clearances under product code DDI with a decision year between 1978 and 1984, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DDI by decision year
YearClearances
19781
19841

Applicants with the most clearances

Product code DDI
Applicants holding the most 510(k) clearances under product code DDI
ApplicantClearances
Gelman Instrument Co.1
Intl. Diagnostic Technology1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code DDI.