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)

HEMOCUE GLUCOLIN

K-Number: K963909 · 1996-11-08

ApplicantDirect Solutions
Decision Date1996-11-08
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HEMOCUE GLUCOLIN is the device name listed in this FDA 510(k) record. The listed applicant is Direct Solutions. It received FDA 510(k) clearance on 1996-11-08 under 510(k) number K963909. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOCUE GLUCOLIN?

HEMOCUE GLUCOLIN is a medical device that received FDA 510(k) clearance on 1996-11-08. The listed applicant is Direct Solutions. The 510(k) number is K963909.

When did HEMOCUE GLUCOLIN receive FDA 510(k) clearance?

HEMOCUE GLUCOLIN received FDA 510(k) clearance on 1996-11-08, under 510(k) number K963909.

Who is the listed applicant for HEMOCUE GLUCOLIN?

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

What is the FDA product code for HEMOCUE GLUCOLIN?

The FDA product code for HEMOCUE GLUCOLIN is JJX.

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 Direct Solutions 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.

K964052HEMOCUE HEMOTROLK964053HEMOCUE GLUCOTROLK963908HEMOCUE HEMOLINK955340EUROTROL GAS - ISE CONTROL

Related Devices (Code: JJX)

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.

K170678Beta-CrossLaps CalCheck 5Roche DiagnosticsK162173Elecsys CYFRA 21-1 CalCheck 5Roche DiagnosticsK162514Multichem A1cTechnopath ManufacturingK161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.K161522LIAISON EBV IgM Serum Control SetDiaSorin, 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.

↑