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

D/Km-1, Antigen, Antiserum, Control

21 CFR 866.5065 / Immunology
FDA source (opens on fda.gov)

DHF is the FDA product code for D/Km-1, Antigen, Antiserum, Control, a class I device type, regulated under 21 CFR 866.5065. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
DHF
Device name
D/Km-1, Antigen, Antiserum, Control
Regulation
21 CFR 866.5065
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
1
Ingested recalls
0

Clearances, product code DHF

By decision year
1 clearance under product code DHF with a decision year between 1994 and 1994, 1994 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DHF by decision year
YearClearances
19941

Applicants with the most clearances

Product code DHF
Applicants holding the most 510(k) clearances under product code DHF
ApplicantClearances
Ventana Medical Systems Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

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