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510(k) K073091

VIDAS NT-PROBNP ASSAY, MODEL: 30 449 by bioMerieux, Inc. — Product Code NBC

K073091 is an FDA 510(k) premarket notification submitted by bioMerieux, Inc. for the device "VIDAS NT-PROBNP ASSAY, MODEL: 30 449". The FDA issued a decision of Substantially Equivalent on February 29, 2008. The device falls under product code NBC (Test, Natriuretic Peptide), a Class II device regulated under 21 CFR 862.1117. bioMerieux, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 29, 2008
Date Received
November 1, 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

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Other clearances for product code NBC

  • K252169 — Access BNP II (March 24, 2026)
  • 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)

FDA data resources