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

Complement C4, Antigen, Antiserum, Control

21 CFR 866.5240 / Immunology
FDA source (opens on fda.gov)

DBI is the FDA product code for Complement C4, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5240. As of , FDA records hold 34 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
DBI
Device name
Complement C4, Antigen, Antiserum, Control
Regulation
21 CFR 866.5240
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
34
Ingested recalls
2

Clearances, product code DBI

By decision year
34 clearances under product code DBI with a decision year between 1977 and 2010, 1977 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DBI by decision year
YearClearances
19773
19781
19802
19812
19832
19841
19852
19861
19873
19881
19892
19911
19921
19962
19972
19981
19992
20002
20012
20101

Applicants with the most clearances

Product code DBI
Applicants holding the most 510(k) clearances under product code DBI
ApplicantClearances
Boehringer Mannheim Corp.2
Crestat Diagnostics, Inc.2
Dako Corp.2
G.D. Searle and Co.2
Instrumentation Laboratory Co.2
Kallestad Laboratories, Inc.2
Technicon Instruments Corp.2
The Binding Site2
Abbott Medical1
Applications Lab1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order