Cleared Traditional

IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96

K020583 · Ivd Research, Inc. · Microbiology
Sep 2002
Decision
208d
Days
Class 2
Risk

About This 510(k) Submission

K020583 is an FDA 510(k) clearance for the IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96, a Giardia Spp. (Class II — Special Controls, product code MHI), submitted by Ivd Research, Inc. (Carlsbad, US). The FDA issued a Cleared decision on September 17, 2002, 208 days after receiving the submission on February 21, 2002. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K020583 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2002
Decision Date September 17, 2002
Days to Decision 208 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code MHI — Giardia Spp.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3220

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