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510(k) K081064

Device
GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
Applicant
IVD RESEARCH, INC.
510(k) number
K081064
Product code
MHI  
Decision
Substantially Equivalent (SESE)
Decision date
2009-01-14
Date received
2008-04-14
Regulation
866.3220
Classification name
Giardia Spp.
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL WIENHOLT
Address
5470 E. Edwin Rd. Tucson AZ US 85739 85739

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MHI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K120001UNIGOLD GIARDIATrinity Biotech2013-03-01
K103673GIARDIA/ CRYPTOSPORIDIUM QUIK CHEKTechlab Inc., Corporate Research Center2011-08-18
K031942XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020Remel, Inc.2003-11-18
K031834XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAYRemel, Inc.2003-11-10
K033274GIARDIA IITechlab, Inc.2003-11-04
K024113IVD CRYPTO/GIARDIA DFAIvd Research, Inc.2003-03-05
K020583IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96Ivd Research, Inc.2002-09-17
K983399GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAYGenzyme Diagnostics1999-01-11
K982711PREMIER GIARDIAMeridian Diagnostics, Inc.1998-11-25
K982245TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIABiosite Incorporated1998-10-06
K963135GIARDIA CELISATechlab, Inc.1996-11-29
K955897CRYPTO/GIARDIA-CEL IF TESTTechlab, Inc.1996-08-05
K955157PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAYAlexon Biomedical, Inc.1996-02-09
K952467TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT)Trend Scientific, Inc.1995-11-20
K953284TREND GIARDIA DIRECT DETECTION RS TEST SYSTEMTrend Scientific, Inc.1995-10-06

Legacy Summary#

summary

FDA Review#

Decision Summary