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FDA 510(k)

HEMOCUE HEMOTROL

K-Number: K964052 · 1996-11-06

ApplicantDirect Solutions
Decision Date1996-11-06
Product CodeGGM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCUE HEMOTROL is the device name listed in this FDA 510(k) record. The listed applicant is Direct Solutions. It received FDA 510(k) clearance on 1996-11-06 under 510(k) number K964052. 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 HEMOTROL?

HEMOCUE HEMOTROL is a medical device that received FDA 510(k) clearance on 1996-11-06. The listed applicant is Direct Solutions. The 510(k) number is K964052.

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

HEMOCUE HEMOTROL received FDA 510(k) clearance on 1996-11-06, under 510(k) number K964052.

Who is the listed applicant for HEMOCUE HEMOTROL?

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 HEMOTROL?

The FDA product code for HEMOCUE HEMOTROL 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 GLUCOLINK964053HEMOCUE GLUCOTROLK963908HEMOCUE HEMOLINK955340EUROTROL 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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