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

Lambda, Antigen, Antiserum, Control

21 CFR 866.5550 / Immunology
FDA source (opens on fda.gov)

DEH is the FDA product code for Lambda, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5550. As of , FDA records hold 53 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
DEH
Device name
Lambda, Antigen, Antiserum, Control
Regulation
21 CFR 866.5550
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
53
Ingested recalls
4

Clearances, product code DEH

By decision year
53 clearances under product code DEH with a decision year between 1977 and 2018, 1997 the highest year at 11.
Show the numbers
510(k) clearances under FDA product code DEH by decision year
YearClearances
19771
19782
19792
19811
19832
19842
19851
19862
19881
19902
19931
19943
19954
19968
199711
20001
20013
20032
20041
20091
20141
20181

Applicants with the most clearances

Product code DEH
Applicants holding the most 510(k) clearances under product code DEH
ApplicantClearances
Ventana Medical Systems Inc17
Dako Corp.8
The Binding Site7
Biotek Solutions, Inc.4
Kallestad Laboratories, Inc.4
Gelco Diagnostics, Inc.2
Icl Scientific2
Bartels Immunodiagnostic Supplies, Inc.1
Beckman Instruments, Inc.1
Dako Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order