Cleared Traditional

XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY

K031834 · Remel, Inc. · Microbiology
Nov 2003
Decision
150d
Days
Class 2
Risk

About This 510(k) Submission

K031834 is an FDA 510(k) clearance for the XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY, a Giardia Spp. (Class II — Special Controls, product code MHI), submitted by Remel, Inc. (Lenexa, US). The FDA issued a Cleared decision on November 10, 2003, 150 days after receiving the submission on June 13, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K031834 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2003
Decision Date November 10, 2003
Days to Decision 150 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