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

Igg (Fab Fragment Specific), Antigen, Antiserum, Control

21 CFR 866.5520 / Immunology
FDA source (opens on fda.gov)

DFK is the FDA product code for Igg (Fab Fragment Specific), Antigen, Antiserum, Control, a class I device type, regulated under 21 CFR 866.5520. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DFK
Device name
Igg (Fab Fragment Specific), Antigen, Antiserum, Control
Regulation
21 CFR 866.5520
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
3
Ingested recalls
0

Clearances, product code DFK

By decision year
3 clearances under product code DFK with a decision year between 1977 and 1979, 1977 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DFK by decision year
YearClearances
19772
19791

Applicants with the most clearances

Product code DFK
Applicants holding the most 510(k) clearances under product code DFK
ApplicantClearances
Kent Laboratories, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code