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

Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control

21 CFR 866.5130 / Immunology
FDA source (opens on fda.gov)

DFB is the FDA product code for Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5130. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
DFB
Device name
Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control
Regulation
21 CFR 866.5130
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
1
Ingested recalls
0

Clearances, product code DFB

By decision year
1 clearance under product code DFB with a decision year between 1983 and 1983, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DFB by decision year
YearClearances
19831

Applicants with the most clearances

Product code DFB
Applicants holding the most 510(k) clearances under product code DFB
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic1

Companies listing this code with FDA

Companies whose registered establishments list this code

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