JXB — Kit, Identification, Yeast Class I

FDA Device Classification

Classification Details

Product Code
JXB
Device Class
Class I
Regulation Number
866.2660
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K080719advandxYEAST TRAFFIC LIGHT PNA FISHSeptember 12, 2008
K062461advandxC. ALBICANS PNA FISHOctober 25, 2006
K993554diagnostic markersYEASTESTFebruary 10, 2000
K943621innovative diagnostic systemsRAPID YEAST PLUS SYSTEMJanuary 27, 1995
K935124remelBACTICARD CANDIDAFebruary 25, 1994
K900112medical wire and equipmentMICRORING YTJuly 31, 1990
K881925vitek systemsVITEK YEAST BIOCHEMICAL CARDJune 16, 1988
K860575american micro scanYEAST IDENTIFICATION PANELMay 13, 1986
K830286analytical productsYEAST IDENTApril 5, 1983
K802309abbott laboratoriesMS-2 IDENTIFICATION SYSTEMDecember 1, 1980
K800803remelNITRATE SWAB-RAPID TESTJuly 8, 1980
K800908immuno-mycologicsCAPIK-CANDIDA ALBICANS IDENT. KIT.June 2, 1980
K792231vitek systemsAMS YEAST BIOCHEMICAL CARDDecember 19, 1979
K790991micro-palettesYEAST-PALETTE TMJune 22, 1979
K790671diagnosticaDERMATOPHYTIN OMay 31, 1979
K771008analytical productsAPI 20CAugust 3, 1977