FDA.reportPublic FDA data

510(k) K031965

Device
XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
Applicant
REMEL INC
510(k) number
K031965
Product code
MHJ  
Decision
Substantially Equivalent (SESE)
Decision date
2003-11-14
Date received
2003-06-26
Regulation
866.3220
Classification name
Cryptosporidium Spp.
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RICHARD TYSON
Address
1400 Unity St. Northwest Ramsey MN US 55303 55303

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MHJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K171078TRI-COMBO PARASITE SCREENTechlab, Inc.2017-07-10
K121565UNI-GOLD CRYPTOSPORIDIUMTrinity Biotech2013-02-08
K051929GIARDIA/CRYPTOSPORIDIUM CHEKTechlab, Inc.2005-11-17
K052932CRYPTOSPORIDIUM IITechlab, Inc.2005-11-04
K031059IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96Ivd Research, Inc.2003-07-10
K982764PREMIER CRYPTOSPORIDIUMMeridian Diagnostics, Inc.1998-12-03
K982709MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAYAlexon - Trend, Inc.1998-09-03
K980354CRYPTOSPORIDIUM TESTTechlab, Inc.1998-05-18
K955852CRYPTO-CEL IF TESTTechlab, Inc.1996-08-05
K955755TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMSTrend Scientific, Inc.1996-07-11
K955345LMD CRYPTOSPORIDIUM ANTIGEN DETECTIONLmd Laboratories1996-06-07
K936191PROSPECT CRYPTOSPORIDIUM RAPID ASSAYAlexon Biomedical, Inc.1994-11-17
K912242PROSPECT(TM/CRYPTOSPORIDIUMAlexon, Inc.1992-03-23
K905598CRYPTOSPORIDIUM ANTIGEN DETECTIONLmd Laboratories1991-09-05

Legacy Summary#

summary

FDA Review#

Decision Summary