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

Fc, Antigen, Antiserum, Control

21 CFR 866.5530 / Immunology
FDA source (opens on fda.gov)

DBN is the FDA product code for Fc, Antigen, Antiserum, Control, a class I device type, regulated under 21 CFR 866.5530. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
DBN
Device name
Fc, Antigen, Antiserum, Control
Regulation
21 CFR 866.5530
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 DBN

By decision year
1 clearance under product code DBN with a decision year between 1989 and 1989, 1989 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DBN by decision year
YearClearances
19891

Applicants with the most clearances

Product code DBN
Applicants holding the most 510(k) clearances under product code DBN
ApplicantClearances
Kallestad Diag, A Div. of Erbamont, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code