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

Complement C9, Antigen, Antiserum, Control

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

DAE is the FDA product code for Complement C9, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5240. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DAE
Device name
Complement C9, 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
6
Ingested recalls
0

Clearances, product code DAE

By decision year
6 clearances under product code DAE with a decision year between 1995 and 2015, 1995 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DAE by decision year
YearClearances
19952
19981
19991
20121
20151

Applicants with the most clearances

Product code DAE
Applicants holding the most 510(k) clearances under product code DAE
ApplicantClearances
The Binding Site Group Ltd.2
Incstar Corp.1
Ortho-Clinical Diagnostics, Inc.1
The Binding Site1
FUJIFILM Healthcare Americas Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code