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MKW — Cyclosporine Class II

FDA Device Classification

Classification Details

Product Code
MKW
Device Class
Class II
Regulation Number
862.1235
Submission Type
Review Panel
TX
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K080751fujirebio diagnosticsARCHITECT CYCLOSPORINESeptember 11, 2008
K071455siemens medical solutions diagnosticsADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATORSeptember 11, 2008
K081992siemens healthcare diagnosticsDIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108August 5, 2008
K062236dade behringDIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGEAugust 21, 2006
K053061dade behringEMIT 2000 CYCLOSPORINE SPECIFIC ASSAYFebruary 6, 2006
K052017dade behringCYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108September 1, 2005
K040761abbott laboratoriesAXSYM CYCLOSPORINEApril 30, 2004
K023208microgenicsCEDIA CYCLOSPORINE PLUS ASSAYOctober 24, 2002
K023065dade behringCYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGEOctober 16, 2002