510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DFDClass II

Kappa, Peroxidase, Antigen, Antiserum, Control

21 CFR 866.5550 / Immunology
FDA source (opens on fda.gov)

DFD is the FDA product code for Kappa, Peroxidase, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5550. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DFD
Device name
Kappa, Peroxidase, Antigen, Antiserum, Control
Regulation
21 CFR 866.5550
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
3
Ingested recalls
0

Clearances, product code DFD

By decision year
3 clearances under product code DFD with a decision year between 1993 and 1996, 1993 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DFD by decision year
YearClearances
19932
19961

Applicants with the most clearances

Product code DFD
Applicants holding the most 510(k) clearances under product code DFD
ApplicantClearances
Ventana Medical Systems Inc3

Companies listing this code with FDA

Companies whose registered establishments list this code

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