Product code MKW— Clinical Chemistry
ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR
- Classification name
- Cyclosporine
- Device class
- Class 2
- Regulation
- 21 CFR 862.1235
- Advisory panel
- Clinical Chemistry
- Total cleared
- 9
- First cleared
- Most recent
Market context for product code MKW
FDA has cleared devices under product code MKW between 2002 and 2008, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2008
- 2006
- 2005
- 2004
- 2002
Top applicants under product code MKW
Recent clearances under product code MKW
- K071455 — ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR
- K080751 — ARCHITECT CYCLOSPORINE
- K081992 — DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
- K062236 — DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
- K053061 — EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
- K052017 — CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108
- K040761 — AXSYM CYCLOSPORINE
- K023208 — CEDIA CYCLOSPORINE PLUS ASSAY
- K023065 — CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
Data sourced from openFDA. This site is unofficial and independent of the FDA.