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Device Classification
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GWD — Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
Class II
FDA Device Classification
Classification Details
Product Code
GWD
Device Class
Class II
Regulation Number
866.3220
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No
Recent 510(k) Clearances
K-Number
Applicant
Device Name
Date
K873299
meridian diagnostics
MERIFLUOR(TM)-GIARDIA
September 16, 1987
K844836
edward weck
HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER
January 23, 1985