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)

CLINICAL LABORATORY ANALYZING SYSTEM

K-Number: K041230 · 2004-05-20

ApplicantHemocue, Inc.
Decision Date2004-05-20
Product CodeLFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLINICAL LABORATORY ANALYZING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hemocue, Inc.. It received FDA 510(k) clearance on 2004-05-20 under 510(k) number K041230. The device is classified under product code LFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINICAL LABORATORY ANALYZING SYSTEM?

CLINICAL LABORATORY ANALYZING SYSTEM is a medical device that received FDA 510(k) clearance on 2004-05-20. The listed applicant is Hemocue, Inc.. The 510(k) number is K041230.

When did CLINICAL LABORATORY ANALYZING SYSTEM receive FDA 510(k) clearance?

CLINICAL LABORATORY ANALYZING SYSTEM received FDA 510(k) clearance on 2004-05-20, under 510(k) number K041230.

Who is the listed applicant for CLINICAL LABORATORY ANALYZING SYSTEM?

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

What is the FDA product code for CLINICAL LABORATORY ANALYZING SYSTEM?

The FDA product code for CLINICAL LABORATORY ANALYZING SYSTEM is LFR.

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 Hemocue, 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.

K041234HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEMK032203HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704K020935HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706K962415HEMOCUE B-GLCOSE SYSTEMK961312HEMOCUE B-HEMOGLOBIN SYSTEMK961311HEMOCUE B-GLUCOSE SYSTEM

View all 9 devices →

Related Devices (Code: LFR)

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.

K131366ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEMRoche Diagnostics Operations, Inc.K122688NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITORNova Biomedical CorporationK121433GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMSHmd Biomedical, Inc.K122435NOVA ONE BLOOD GLUCOSE MONITORNova Biomedical CorporationK113314PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMHmd Biomedical, Inc.K121224GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation

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.

↑