Home / 510(k) Clearances / K072189

510(k) K072189

PATHFAST NTPROBNP AND D-DIMER TESTS by Mitsubishi Kagaku Iatron — Product Code NBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2008
Date Received
August 6, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Natriuretic Peptide
Device Class
Class II
Regulation Number
862.1117
Review Panel
CH
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)
  • K083412 — PATHFAST HSCRP (March 9, 2009)

Other clearances for product code NBC

  • K253539 — Alere NT-proBNP for Alinity i (February 18, 2026)
  • K241176 — Alere NT-proBNP for Alinity i Reagent Kit (January 16, 2025)
  • K232164 — Access NT-proBNP (April 12, 2024)
  • K220265 — ADVIA Centaur® NT-proBNPII (PBNPII) (September 24, 2023)
  • K223637 — Elecsys proBNP II, Elecsys proBNP II STAT (July 21, 2023)
  • K210546 — Elecsys proBNP II, Elecsys proBNP II STAT (March 31, 2022)
  • K211199 — ST AIA-PACK BNP Assay (November 8, 2021)
  • K201312 — VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack (October 4, 2021)
  • K192380 — ST AIA-PACK BNP (August 24, 2020)
  • K092649 — ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109 (February 4, 2010)