Cleared Traditional

GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF

K081064 · Ivd Research, Inc. · Microbiology
Jan 2009
Decision
275d
Days
Class 2
Risk

About This 510(k) Submission

K081064 is an FDA 510(k) clearance for the GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF, a Giardia Spp. (Class II — Special Controls, product code MHI), submitted by Ivd Research, Inc. (Tucson, US). The FDA issued a Cleared decision on January 14, 2009, 275 days after receiving the submission on April 14, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K081064 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2008
Decision Date January 14, 2009
Days to Decision 275 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

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