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510(k) K210546

Elecsys proBNP II, Elecsys proBNP II STAT by Roche Diagnostics — Product Code NBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2022
Date Received
February 25, 2021
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

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Other clearances for product code NBC

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  • K220265 — ADVIA Centaur® NT-proBNPII (PBNPII) (September 24, 2023)
  • K223637 — Elecsys proBNP II, Elecsys proBNP II STAT (July 21, 2023)
  • 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)
  • K082645 — DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRI (September 22, 2008)