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 CARDIAC-1 CRP RAPID TEST, MODEL BC-804114

K-Number: K040030 · 2004-06-16

ApplicantBiocheck, Inc.
Decision Date2004-06-16
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 is the device name listed in this FDA 510(k) record. The listed applicant is Biocheck, Inc.. It received FDA 510(k) clearance on 2004-06-16 under 510(k) number K040030. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114?

BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 is a medical device that received FDA 510(k) clearance on 2004-06-16. The listed applicant is Biocheck, Inc.. The 510(k) number is K040030.

When did BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 receive FDA 510(k) clearance?

BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 received FDA 510(k) clearance on 2004-06-16, under 510(k) number K040030.

Who is the listed applicant for BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114?

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 CARDIAC-1 CRP RAPID TEST, MODEL BC-804114?

The FDA product code for BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 is DCN.

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 #801116K022660BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117K013062BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KITK003851BIOCHECK 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: DCN)

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.

K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbHK221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group , Ltd.K172868Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein ControlsThe Binding Site Group , Ltd.K171498MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentMeso Scale Diagnostics, LLC

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.

↑