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510(k) K080751

ARCHITECT CYCLOSPORINE by Fujirebio Diagnostics,Inc. — Product Code MKW

K080751 is an FDA 510(k) premarket notification submitted by Fujirebio Diagnostics,Inc. for the device "ARCHITECT CYCLOSPORINE". The FDA issued a decision of Substantially Equivalent on September 11, 2008. The device falls under product code MKW (Cyclosporine), a Class II device regulated under 21 CFR 862.1235. Fujirebio Diagnostics,Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2008
Date Received
March 18, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cyclosporine
Device Class
Class II
Regulation Number
862.1235
Review Panel
TX
Submission Type

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  • K172713 — Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S P (December 10, 2017)
  • K171103 — Lumipulse G TSH-III Immunoreaction Cartridges (July 28, 2017)
  • K163546 — Lumipulse G Progesterone-N Calibrators (January 13, 2017)

Other clearances for product code MKW

  • K071455 — ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR (September 11, 2008)
  • K081992 — DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 (August 5, 2008)
  • K062236 — DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE (August 21, 2006)
  • K053061 — EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (February 6, 2006)
  • K052017 — CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 (September 1, 2005)
  • K040761 — AXSYM CYCLOSPORINE (April 30, 2004)
  • K023208 — CEDIA CYCLOSPORINE PLUS ASSAY (October 24, 2002)
  • K023065 — CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE (October 16, 2002)

FDA data resources