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FDA 510(k)

I-STAT CREATINE KINASE MB (CK-MB)

K-Number: K051433 · 2005-12-15

ApplicantI-Stat Corporation
Decision Date2005-12-15
Product CodeMYT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

I-STAT CREATINE KINASE MB (CK-MB) 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 2005-12-15 under 510(k) number K051433. The device is classified under product code MYT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-STAT CREATINE KINASE MB (CK-MB)?

I-STAT CREATINE KINASE MB (CK-MB) is a medical device that received FDA 510(k) clearance on 2005-12-15. The listed applicant is I-Stat Corporation. The 510(k) number is K051433.

When did I-STAT CREATINE KINASE MB (CK-MB) receive FDA 510(k) clearance?

I-STAT CREATINE KINASE MB (CK-MB) received FDA 510(k) clearance on 2005-12-15, under 510(k) number K051433.

Who is the listed applicant for I-STAT CREATINE KINASE MB (CK-MB)?

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 CREATINE KINASE MB (CK-MB)?

The FDA product code for I-STAT CREATINE KINASE MB (CK-MB) is MYT.

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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+ CartridgeK031873I-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: MYT)

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.

K033155BIOCENTREX CARDIAC PANELBiocentrexK984433QUANTECH CK-MB ASSAYQuantech , Ltd.

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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