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

Ng3m(Bo), Antigen, Antiserum, Control

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

DHI is the FDA product code for Ng3m(Bo), 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
DHI
Device name
Ng3m(Bo), 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 DHI

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

Applicants with the most clearances

Product code DHI
Applicants holding the most 510(k) clearances under product code DHI
ApplicantClearances
Serono Laboratories, 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 DHI.