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Device Classification
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GNH — Antigen, Fluorescent Antibody Test, Schistosoma Mansoni
Class I
FDA Device Classification
Classification Details
Product Code
GNH
Device Class
Class I
Regulation Number
866.3600
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No
Recent 510(k) Clearances
K-Number
Applicant
Device Name
Date
K842660
amico lab
ANTI-SCHISTOSOMA SPECIES KIT
October 30, 1984
K842527
amico lab
AMIZYME-SCHISTOSOMA SPP. TEST KIT
September 5, 1984