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

Alpha-1-Antitrypsin, Antigen, Antiserum, Control

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

DEM is the FDA product code for Alpha-1-Antitrypsin, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5130. As of , FDA records hold 30 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
DEM
Device name
Alpha-1-Antitrypsin, 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
30
Ingested recalls
1

Clearances, product code DEM

By decision year
30 clearances under product code DEM with a decision year between 1976 and 2013, 1997 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code DEM by decision year
YearClearances
19762
19782
19791
19801
19851
19883
19891
19911
19921
19941
19976
19981
19991
20012
20031
20052
20061
20071
20131

Applicants with the most clearances

Product code DEM
Applicants holding the most 510(k) clearances under product code DEM
ApplicantClearances
Ventana Medical Systems Inc5
Siemens Healthcare Diagnostics Inc.2
Kallestad Diag, A Div. of Erbamont, Inc.2
The Binding Site2
Applications Lab1
Atlantic Antibodies1
Bayer Diagnostics Corp.1
Beckman Instruments, Inc.1
Biokit, S.A.1
Boehringer Mannheim Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order