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FDA 510(k)

HEMOCUE HEMOLIN

K-Number: K963908 · 1996-10-16

ApplicantDirect Solutions
Decision Date1996-10-16
Product CodeGGM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCUE HEMOLIN is the device name listed in this FDA 510(k) record. The listed applicant is Direct Solutions. It received FDA 510(k) clearance on 1996-10-16 under 510(k) number K963908. The device is classified under product code GGM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOCUE HEMOLIN?

HEMOCUE HEMOLIN is a medical device that received FDA 510(k) clearance on 1996-10-16. The listed applicant is Direct Solutions. The 510(k) number is K963908.

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

HEMOCUE HEMOLIN received FDA 510(k) clearance on 1996-10-16, under 510(k) number K963908.

Who is the listed applicant for HEMOCUE HEMOLIN?

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 HEMOLIN?

The FDA product code for HEMOCUE HEMOLIN is GGM.

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.

K963909HEMOCUE GLUCOLINK964052HEMOCUE HEMOTROLK964053HEMOCUE GLUCOTROLK955340EUROTROL GAS - ISE CONTROL

Related Devices (Code: GGM)

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.

K192842HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo HighEurotrol B.V.K182744HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighEurotrol B.V.K070546LYPHOCHEK DIABETES CONTROLBio-Rad LaboratoriesK070334R&D SICKLE QC CONTROLR&D Systems, Inc.K052838LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4Bio-RadK032791GLYCOHEMOSURE HBA1C CONTROLQuantimetrix Corp.

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.

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