Cleared Traditional

GIARDEIA(TM)

K890774 · Antibodies, Inc. · Microbiology
Apr 1989
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K890774 is an FDA 510(k) clearance for the GIARDEIA(TM), a Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. (Class II — Special Controls, product code KHW), submitted by Antibodies, Inc. (Davis, US). The FDA issued a Cleared decision on April 4, 1989, 48 days after receiving the submission on February 15, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K890774 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 1989
Decision Date April 04, 1989
Days to Decision 48 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code KHW — Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3220

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