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FDA 510(k)

I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)

K-Number: K053597 · 2006-07-21

ApplicantI-Stat Corporation
Decision Date2006-07-21
Product CodeNBC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) is the device name listed in this FDA 510(k) record. The listed applicant is I-Stat Corporation. It received FDA 510(k) clearance on 2006-07-21 under 510(k) number K053597. The device is classified under product code NBC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)?

I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) is a medical device that received FDA 510(k) clearance on 2006-07-21. The listed applicant is I-Stat Corporation. The 510(k) number is K053597.

When did I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) receive FDA 510(k) clearance?

I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) received FDA 510(k) clearance on 2006-07-21, under 510(k) number K053597.

Who is the listed applicant for I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)?

The FDA 510(k) record lists I-Stat Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)?

The FDA product code for I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) is NBC.

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Other records listing I-Stat Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K053110Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ CartridgeK051433I-STAT CREATINE KINASE MB (CK-MB)K031873I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SETK023582I-STAT KAOLIN ACT TESTK031739I-STAT CARDIAC TROPONIN (CTNI) TESTK020355I-STAT PROTHROMBIN TIME TEST

View all 7 devices →

Related Devices (Code: NBC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262109Access NT-proBNPBeckman Coulter, Inc.K252169Access BNP IIBeckman Coulter, Inc.K253539Alere NT-proBNP for Alinity iAxis-Shield Diagnostics, Ltd.K241176Alere NT-proBNP for Alinity i Reagent KitAxis-Shield Diagnostics, Ltd.K232164Access NT-proBNPBeckman Coulter, Inc.K220265ADVIA Centaur® NT-proBNPII (PBNPII)Siemens Healthcare Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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