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

Fab, Rhodamine, Antigen, Antiserum, Control

21 CFR 866.5520 / Immunology
FDA source (opens on fda.gov)

DBY is the FDA product code for Fab, Rhodamine, Antigen, Antiserum, Control, a class I device type, regulated under 21 CFR 866.5520. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DBY
Device name
Fab, Rhodamine, Antigen, Antiserum, Control
Regulation
21 CFR 866.5520
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
6
Ingested recalls
0

Clearances, product code DBY

By decision year
6 clearances under product code DBY with a decision year between 1977 and 2002, 2002 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DBY by decision year
YearClearances
19771
20012
20023

Applicants with the most clearances

Product code DBY
Applicants holding the most 510(k) clearances under product code DBY
ApplicantClearances
Boston Scientific Corporation2
Baylis Medical Co., Inc.1
Becton Dickinson Infusion Therapy Systems Inc.1
Kent Laboratories, Inc.1
W. L. Gore & Associates, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code