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

Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control

21 CFR 866.5250 / Immunology
FDA source (opens on fda.gov)

DBA is the FDA product code for Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5250. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
DBA
Device name
Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
Regulation
21 CFR 866.5250
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
13
Ingested recalls
1

Clearances, product code DBA

By decision year
13 clearances under product code DBA with a decision year between 1978 and 2014, 1978 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DBA by decision year
YearClearances
19782
19821
19871
19921
19951
19961
19971
20012
20071
20131
20141

Applicants with the most clearances

Product code DBA
Applicants holding the most 510(k) clearances under product code DBA
ApplicantClearances
The Binding Site Group Ltd.2
Baxter Healthcare Corporation1
Behring Diagnostics, Inc.1
Crestat Diagnostics, Inc.1
Cytotech, Inc.1
Siemens Healthcare Diagnostics Inc.1
Hyland Therapeutic Div., Travenol Laboratories1
Icl Scientific1
Kamiya Biomedical Company, LLC1
Kent Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code