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

Prothrombin, Antigen, Antiserum, Control

21 CFR 866.5735 / Immunology
FDA source (opens on fda.gov)

DDF is the FDA product code for Prothrombin, Antigen, Antiserum, Control, a class I device type, regulated under 21 CFR 866.5735. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DDF
Device name
Prothrombin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5735
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
2
Ingested recalls
0

Clearances, product code DDF

By decision year
2 clearances under product code DDF with a decision year between 1981 and 1991, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DDF by decision year
YearClearances
19811
19911

Applicants with the most clearances

Product code DDF
Applicants holding the most 510(k) clearances under product code DDF
ApplicantClearances
Hoffmann-La Roche, Inc.1
bioMerieux, 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 DDF.