ClearanceBrief
Panels › Clinical Chemistry › Product code NBC · Class 2

Test, Natriuretic Peptide

Regulation 862.1117

4510(k)s in 12 months (47 all time)
0recalls in 12 months (22 all time)
21recalls that name a 510(k)
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Top companies in NBC

Decided510(k)Device and applicantCode
Oct 20, 2026K262597Access BNP II
Beckman Coulter, Inc.
NBC
Sep 21, 2026K262109Access NT-proBNP
Beckman Coulter, Inc.
NBC
Mar 24, 2026K252169Access BNP II
Beckman Coulter, Inc.
NBC
Feb 18, 2026K253539Alere NT-proBNP for Alinity i
Axis-Shield Diagnostics, Ltd., GB
NBC
Jan 16, 2025K241176Alere NT-proBNP for Alinity i Reagent Kit
Axis-Shield Diagnostics, Ltd., GB
NBC
Apr 12, 2024K232164Access NT-proBNP
Beckman Coulter, Inc.
NBC
Sep 24, 2023K220265ADVIA Centaur® NT-proBNPII (PBNPII)
Siemens Healthcare Diagnostics, Inc.
NBC
Jul 21, 2023K223637Elecsys proBNP II, Elecsys proBNP II STAT
Roche Diagnostics
NBC
Mar 31, 2022K210546Elecsys proBNP II, Elecsys proBNP II STAT
Roche Diagnostics
NBC
Nov 8, 2021K211199ST AIA-PACK BNP Assay
Tosoh Bioscience, Inc.
NBC
Oct 4, 2021K201312VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
Ortho Clinical Diagnostics
NBC
Aug 24, 2020K192380ST AIA-PACK BNP
Fujirebio Diagnostics,Inc.
NBC
Feb 4, 2010K092649ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190
Roche Diagnostics Corp.
NBC
Sep 22, 2008K082645DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623
Siemens Healthcare Diagnostics
NBC
Jul 21, 2008K063662RAMP NT-PROBNP ASSAY
Response Biomedical Corp., CA
NBC
Jun 6, 2008K080269TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS
Biosite Incorporated
NBC
May 16, 2008K080578DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA
Siemens Healthcare Diagnostics, Inc.
NBC
Feb 29, 2008K073091VIDAS NT-PROBNP ASSAY, MODEL: 30 449
bioMerieux, Inc.
NBC
Feb 5, 2008K072437ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET
Roche Diagnostics
NBC
Feb 5, 2008K072189PATHFAST NTPROBNP AND D-DIMER TESTS
Mitsubishi Kagaku Iatron
NBC
Aug 17, 2007K071834STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM
Dade Behring, Inc.
NBC
Aug 4, 2007K071767DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A
Dade Behring, Inc.
NBC
Sep 11, 2006K061795DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR
Dade Behring, Inc.
NBC
Jul 21, 2006K053597I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
I-Stat Corporation
NBC
Jun 6, 2006K060632VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158
Ortho-Clinical Diagnostics, Inc.
NBC
May 25, 2006K060964ARCHITECT BNP ASSAY, MODEL 8K28
Fujirebio Diagnostics,Inc.
NBC
Mar 13, 2006K051596STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204
Nanogen, Inc.
NBC
Jan 23, 2006K052789TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200
Biosite Incorporated
NBC
Dec 5, 2005K051382ELECSYS PROBNP IMMUNOASSAY
Roche Diagnostics Corp.
NBC
Sep 22, 2005K051787TRIAGE BNP TEST, MODEL 98000XR
Biosite Incorporated
NBC
Jun 13, 2005K051265ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
Bayer Healthcare, LLC
NBC
Apr 22, 2005K043228ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
Bayer Healthcare, LLC
NBC
Feb 15, 2005K043476STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT
Dade Behring, Inc.
NBC
Nov 19, 2004K042347MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD
Dade Behring, Inc.
NBC
Jul 20, 2004K041417DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423
Dade Behring, Inc.
NBC
Jun 14, 2004K040425ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
Bayer Healthcare, LLC
NBC
Jan 30, 2004K033606ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST
Axis-Shield Diagnostics, Ltd., GB
NBC
Jan 28, 2004K032235MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
Biosite Incorporated
NBC
Dec 23, 2003K033383TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200
Biosite Incorporated
NBC
Nov 12, 2003K032646ELECSYS PROBNP IMMUNOASSAY
Roche Diagnostics Corp.
NBC
Sep 9, 2003K032525BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
Bayer Healthcare, LLC
NBC
Jun 23, 2003K031038ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
Bayer Healthcare, LLC
NBC
Feb 21, 2003K030286TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL
Biosite Incorporated
NBC
Nov 19, 2002K022516ELECSYS PROBNP IMMUNOASSAY
Roche Diagnostics Corp.
NBC
Jul 1, 2002K021317TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
Biosite Incorporated
NBC
Mar 16, 2001K010266TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000
Biosite Incorporated
NBC
Nov 20, 2000DEN000010TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
Biosite Incorporated
NBC

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