MKW · Class II · 21 CFR 862.1235

FDA Product Code MKW: Cyclosporine

Leading manufacturers include Dade Behring, Inc. and Siemens Healthcare Diagnostics, Inc..

9
Total
9
Cleared
103d
Avg days
2002
Since

FDA 510(k) Cleared Cyclosporine Devices (Product Code MKW)

9 devices
1–9 of 9
Cleared Aug 05, 2008
DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
K081992
Siemens Healthcare Diagnostics, Inc.
Toxicology · 22d
Cleared Aug 21, 2006
DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
K062236
Dade Behring, Inc.
Chemistry · 19d
Cleared Feb 06, 2006
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
K053061
Dade Behring, Inc.
Toxicology · 98d
Cleared Sep 01, 2005
CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108
K052017
Dade Behring, Inc.
Toxicology · 37d
Cleared Oct 16, 2002
CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
K023065
Dade Behring, Inc.
Chemistry · 30d

About Product Code MKW - Regulatory Context