Cleared Traditional

XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020

K031942 · Remel, Inc. · Microbiology
Nov 2003
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K031942 is an FDA 510(k) clearance for the XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020, a Giardia Spp. (Class II — Special Controls, product code MHI), submitted by Remel, Inc. (Ramsey, US). The FDA issued a Cleared decision on November 18, 2003, 147 days after receiving the submission on June 24, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K031942 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2003
Decision Date November 18, 2003
Days to Decision 147 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