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

Antigen, Latex Agglutination, T. Cruzi

21 CFR 866.3870 / Microbiology
FDA source (opens on fda.gov)

GNE is the FDA product code for Antigen, Latex Agglutination, T. Cruzi, a class I device type, regulated under 21 CFR 866.3870. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
GNE
Device name
Antigen, Latex Agglutination, T. Cruzi
Regulation
21 CFR 866.3870
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code GNE

By decision year
1 clearance under product code GNE with a decision year between 1984 and 1984, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GNE by decision year
YearClearances
19841

Applicants with the most clearances

Product code GNE
Applicants holding the most 510(k) clearances under product code GNE
ApplicantClearances
Sero-Immuno Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code GNE.