Home / 510(k) Clearances / K053597

510(k) K053597

I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) by I-Stat Corporation — Product Code NBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2006
Date Received
December 23, 2005
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 I-Stat Corporation

  • K053110 — Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartri (January 13, 2006)
  • K051433 — I-STAT CREATINE KINASE MB (CK-MB) (December 15, 2005)
  • K031873 — I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VE (October 7, 2003)
  • K023582 — I-STAT KAOLIN ACT TEST (September 8, 2003)
  • K031739 — I-STAT CARDIAC TROPONIN (CTNI) TEST (September 2, 2003)
  • K020355 — I-STAT PROTHROMBIN TIME TEST (May 14, 2002)

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)