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)

BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT

K-Number: K013062 · 2002-01-08

ApplicantBiocheck, Inc.
Decision Date2002-01-08
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biocheck, Inc.. It received FDA 510(k) clearance on 2002-01-08 under 510(k) number K013062. 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 BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT?

BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT is a medical device that received FDA 510(k) clearance on 2002-01-08. The listed applicant is Biocheck, Inc.. The 510(k) number is K013062.

When did BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT receive FDA 510(k) clearance?

BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT received FDA 510(k) clearance on 2002-01-08, under 510(k) number K013062.

Who is the listed applicant for BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT?

The FDA 510(k) record lists Biocheck, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT?

The FDA product code for BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT 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 Biocheck, Inc. 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.

K041619BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116K040030BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114K022660BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117K003851BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119K002294BIOCHECK TESTOSTERONE EIA, MODEL BC-1115K001022BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061

View all 14 devices →

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.

↑