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FDA 510(k)

I-STAT CARDIAC TROPONIN (CTNI) TEST

K-Number: K031739 · 2003-09-02

ApplicantI-Stat Corporation
Decision Date2003-09-02
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

I-STAT CARDIAC TROPONIN (CTNI) TEST 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 2003-09-02 under 510(k) number K031739. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-STAT CARDIAC TROPONIN (CTNI) TEST?

I-STAT CARDIAC TROPONIN (CTNI) TEST is a medical device that received FDA 510(k) clearance on 2003-09-02. The listed applicant is I-Stat Corporation. The 510(k) number is K031739.

When did I-STAT CARDIAC TROPONIN (CTNI) TEST receive FDA 510(k) clearance?

I-STAT CARDIAC TROPONIN (CTNI) TEST received FDA 510(k) clearance on 2003-09-02, under 510(k) number K031739.

Who is the listed applicant for I-STAT CARDIAC TROPONIN (CTNI) TEST?

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 CARDIAC TROPONIN (CTNI) TEST?

The FDA product code for I-STAT CARDIAC TROPONIN (CTNI) TEST is MMI.

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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.

K053597I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)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 TESTK020355I-STAT PROTHROMBIN TIME TEST

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Related Devices (Code: MMI)

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.

K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc.K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc.K243483Access hsTnIBeckman Coulter, Inc.K242870Access hsTnIBeckman Coulter, Inc.K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K241165Atellica® IM High-Sensitivity Troponin I (TnIH)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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