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

Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp

21 CFR 866.3220 / Microbiology
FDA source (opens on fda.gov)

GWD is the FDA product code for Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp, a class II device type, regulated under 21 CFR 866.3220. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
GWD
Device name
Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
Regulation
21 CFR 866.3220
Device class
Class II
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
3

Clearances, product code GWD

By decision year
2 clearances under product code GWD with a decision year between 1985 and 1987, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GWD by decision year
YearClearances
19851
19871

Applicants with the most clearances

Product code GWD
Applicants holding the most 510(k) clearances under product code GWD
ApplicantClearances
Edward Weck, Inc.1
Meridian Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code