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

Ige, Peroxidase, Antigen, Antiserum, Control

21 CFR 866.5510 / Immunology
FDA source (opens on fda.gov)

DGO is the FDA product code for Ige, Peroxidase, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5510. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DGO
Device name
Ige, Peroxidase, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
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
15
Ingested recalls
0

Clearances, product code DGO

By decision year
15 clearances under product code DGO with a decision year between 1980 and 1995, 1983 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code DGO by decision year
YearClearances
19801
19821
19835
19851
19861
19871
19892
19911
19921
19951

Applicants with the most clearances

Product code DGO
Applicants holding the most 510(k) clearances under product code DGO
ApplicantClearances
Diagnostic Reagent Tech.5
Siemens Healthcare Diagnostics Inc.3
Beckman Instruments, Inc.2
Calbiochem-Behring Corp.1
Dexall Biomedical Labs, Inc.1
Nichols Institute Diagnostics1
Ortho-Clinical Diagnostics, Inc.1
The Binding Site1

Companies listing this code with FDA

Companies whose registered establishments list this code