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

Alpha-2-Macroglobulin, Antigen, Antiserum, Control

21 CFR 866.5620 / Immunology
FDA source (opens on fda.gov)

DEB is the FDA product code for Alpha-2-Macroglobulin, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5620. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DEB
Device name
Alpha-2-Macroglobulin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5620
Device class
Class II
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
13
Ingested recalls
0

Clearances, product code DEB

By decision year
13 clearances under product code DEB with a decision year between 1977 and 2014, 1985 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DEB by decision year
YearClearances
19772
19791
19811
19853
19891
19911
19981
20061
20081
20141

Applicants with the most clearances

Product code DEB
Applicants holding the most 510(k) clearances under product code DEB
ApplicantClearances
Beckman Instruments, Inc.2
Siemens Healthcare Diagnostics Inc.2
Applications Lab1
Cooper Biomedical, Inc.1
Dako Corp.1
Hyland Therapeutic Div., Travenol Laboratories1
Kallestad Diag, A Div. of Erbamont, Inc.1
Kallestad Laboratories, Inc.1
Kent Laboratories, Inc.1
The Binding Site Group Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code