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

Antigen, Fluorescent Antibody Test, Schistosoma Mansoni

21 CFR 866.3600 / Microbiology
FDA source (opens on fda.gov)

GNH is the FDA product code for Antigen, Fluorescent Antibody Test, Schistosoma Mansoni, a class I device type, regulated under 21 CFR 866.3600. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GNH
Device name
Antigen, Fluorescent Antibody Test, Schistosoma Mansoni
Regulation
21 CFR 866.3600
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code GNH

By decision year
2 clearances under product code GNH with a decision year between 1984 and 1984, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GNH by decision year
YearClearances
19842

Applicants with the most clearances

Product code GNH
Applicants holding the most 510(k) clearances under product code GNH
ApplicantClearances
Amico Lab, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order