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510(k) K171078

Device
TRI-COMBO PARASITE SCREEN
Applicant
Techlab, Inc.
510(k) number
K171078
Product code
MHJ  
Decision
Substantially Equivalent (SESE)
Decision date
2017-07-10
Date received
2017-04-11
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
Donna T. Link
Address
2001 Kraft Dr. Blacksburg VA US 24060 24060

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
K121565UNI-GOLD CRYPTOSPORIDIUMTrinity Biotech2013-02-08
K051929GIARDIA/CRYPTOSPORIDIUM CHEKTechlab, Inc.2005-11-17
K052932CRYPTOSPORIDIUM IITechlab, Inc.2005-11-04
K031965XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020Remel, Inc.2003-11-14
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