Cleared Traditional

TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM

K953284 · Trend Scientific, Inc. · Microbiology
Oct 1995
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K953284 is an FDA 510(k) clearance for the TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM, a Giardia Spp. (Class II — Special Controls, product code MHI), submitted by Trend Scientific, Inc. (New Brighton, US). The FDA issued a Cleared decision on October 6, 1995, 85 days after receiving the submission on July 13, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K953284 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1995
Decision Date October 06, 1995
Days to Decision 85 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

Similar Devices — MHI Giardia Spp.

All 26
UNIGOLD GIARDIA
K120001 · Trinity Biotech · Mar 2013
GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK
K103673 · Techlab Inc., Corporate Research Center · Aug 2011
GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
K081064 · Ivd Research, Inc. · Jan 2009
XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
K031942 · Remel, Inc. · Nov 2003
XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
K031834 · Remel, Inc. · Nov 2003
GIARDIA II
K033274 · Techlab, Inc. · Nov 2003