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510(k) K083412

PATHFAST HSCRP by Mitsubishi Kagaku Iatron — Product Code DCN

K083412 is an FDA 510(k) premarket notification submitted by Mitsubishi Kagaku Iatron for the device "PATHFAST HSCRP". The FDA issued a decision of Substantially Equivalent on March 9, 2009. The device falls under product code DCN (System, Test, C-Reactive Protein), a Class II device regulated under 21 CFR 866.5270. Mitsubishi Kagaku Iatron has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2009
Date Received
November 18, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, C-Reactive Protein
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

Other clearances by Mitsubishi Kagaku Iatron

  • K081360 — PATHFAST CK-MB-II, PATHFAST MYO-II (August 17, 2009)
  • K072288 — PATHFAST D-DIMER (May 6, 2009)
  • K072189 — PATHFAST NTPROBNP AND D-DIMER TESTS (February 5, 2008)

Other clearances for product code DCN

  • K232624 — CardioPhase® hsCRP (November 27, 2023)
  • K221119 — RCRP Flex reagent cartridge (March 17, 2023)
  • K192072 — Tina-quant C-Reactive Protein IV (February 21, 2020)
  • K180099 — Optilite High Sensitivity C-Reactive Protein Kit (October 12, 2018)
  • K172868 — Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optil (February 28, 2018)
  • K171498 — MSD CRP Assay Kit and MESO SECTOR S 700 Instrument (January 12, 2018)
  • K161982 — C-Reactive Protein Kit for use on SPAPLUS (April 5, 2017)
  • K113809 — HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) (August 17, 2012)
  • K091052 — PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM (January 15, 2010)
  • K083444 — C-REACTIVE PROTEIN (LATEX) (March 18, 2009)

FDA data resources