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MHJ — Cryptosporidium Spp. Class II

FDA Device Classification

Classification Details

Product Code
MHJ
Device Class
Class II
Regulation Number
866.3220
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K171078techlabTRI-COMBO PARASITE SCREENJuly 10, 2017
K121565trinity biotechUNI-GOLD CRYPTOSPORIDIUMFebruary 8, 2013
K051929techlabGIARDIA/CRYPTOSPORIDIUM CHEKNovember 17, 2005
K052932techlabCRYPTOSPORIDIUM IINovember 4, 2005
K031965remelXPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020November 14, 2003
K031059ivd researchIVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96July 10, 2003
K982764meridian diagnosticsPREMIER CRYPTOSPORIDIUMDecember 3, 1998
K982709alexon - trendMODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAYSeptember 3, 1998
K980354techlabCRYPTOSPORIDIUM TESTMay 18, 1998
K955852techlabCRYPTO-CEL IF TESTAugust 5, 1996
K955755trend scientificTREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMSJuly 11, 1996
K955345lmd laboratoriesLMD CRYPTOSPORIDIUM ANTIGEN DETECTIONJune 7, 1996
K936191alexon biomedicalPROSPECT CRYPTOSPORIDIUM RAPID ASSAYNovember 17, 1994
K912242alexonPROSPECT(TM/CRYPTOSPORIDIUMMarch 23, 1992
K905598lmd laboratoriesCRYPTOSPORIDIUM ANTIGEN DETECTIONSeptember 5, 1991