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510(k) K071455

ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR by Siemens Medical Solutions Diagnostics — Product Code MKW

K071455 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions Diagnostics for the device "ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR". 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. Siemens Medical Solutions Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2008
Date Received
May 25, 2007
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

Other clearances by Siemens Medical Solutions Diagnostics

  • K100910 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 (May 11, 2011)
  • K091984 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 (October 28, 2009)
  • K081895 — ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS (January 8, 2009)
  • K073537 — NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 (June 27, 2008)
  • K072658 — ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS (April 1, 2008)
  • K072794 — IMMULITE 2500 OM-MA, MODEL L5KOP (November 5, 2007)
  • K071466 — DCA VANTAGE, MODEL 5075 (October 9, 2007)
  • K072204 — ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS (October 5, 2007)
  • K070727 — ADVIA CHEMISTRY ENZYMATIC CREATININE_2 (August 3, 2007)
  • K071017 — IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5 (May 2, 2007)

Other clearances for product code MKW

  • K080751 — ARCHITECT CYCLOSPORINE (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