Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN

K-Number: K051925 · 2005-11-29

ApplicantAccess Bio Incorporate
Decision Date2005-11-29
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN is the device name listed in this FDA 510(k) record. The listed applicant is Access Bio Incorporate. It received FDA 510(k) clearance on 2005-11-29 under 510(k) number K051925. 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 CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN?

CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN is a medical device that received FDA 510(k) clearance on 2005-11-29. The listed applicant is Access Bio Incorporate. The 510(k) number is K051925.

When did CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN receive FDA 510(k) clearance?

CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN received FDA 510(k) clearance on 2005-11-29, under 510(k) number K051925.

Who is the listed applicant for CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN?

The FDA 510(k) record lists Access Bio Incorporate as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN?

The FDA product code for CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN is MMI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Access Bio Incorporate 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.

K032159CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCYK031048CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TESTK031052CARESTART HCG ONE-STEP PREGNANCY TEST

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.

↑