ClearanceBrief
Panels › Clinical Chemistry › Product code MKW · Class 2

Cyclosporine

Regulation 862.1235

0510(k)s in 12 months (9 all time)
0recalls in 12 months (5 all time)
4recalls that name a 510(k)
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Top companies in MKW

Decided510(k)Device and applicantCode
Sep 11, 2008K080751ARCHITECT CYCLOSPORINE
Fujirebio Diagnostics,Inc.
MKW
Sep 11, 2008K071455ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR
Siemens Medical Solutions Diagnostics
MKW
Aug 5, 2008K081992DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
Siemens Healthcare Diagnostics, Inc.
MKW
Aug 21, 2006K062236DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
Dade Behring, Inc.
MKW
Feb 6, 2006K053061EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
Dade Behring, Inc.
MKW
Sep 1, 2005K052017CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108
Dade Behring, Inc.
MKW
Apr 30, 2004K040761AXSYM CYCLOSPORINE
Abbott Laboratories, Inc.
MKW
Oct 24, 2002K023208CEDIA CYCLOSPORINE PLUS ASSAY
Microgenics Corp.
MKW
Oct 16, 2002K023065CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
Dade Behring, Inc.
MKW

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