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)

D3 HEMATOLOGY ANALYZER, MODEL D3

K-Number: K071562 · 2007-12-11

ApplicantDrew Scientific, Inc.
Decision Date2007-12-11
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

D3 HEMATOLOGY ANALYZER, MODEL D3 is the device name listed in this FDA 510(k) record. The listed applicant is Drew Scientific, Inc.. It received FDA 510(k) clearance on 2007-12-11 under 510(k) number K071562. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D3 HEMATOLOGY ANALYZER, MODEL D3?

D3 HEMATOLOGY ANALYZER, MODEL D3 is a medical device that received FDA 510(k) clearance on 2007-12-11. The listed applicant is Drew Scientific, Inc.. The 510(k) number is K071562.

When did D3 HEMATOLOGY ANALYZER, MODEL D3 receive FDA 510(k) clearance?

D3 HEMATOLOGY ANALYZER, MODEL D3 received FDA 510(k) clearance on 2007-12-11, under 510(k) number K071562.

Who is the listed applicant for D3 HEMATOLOGY ANALYZER, MODEL D3?

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

What is the FDA product code for D3 HEMATOLOGY ANALYZER, MODEL D3?

The FDA product code for D3 HEMATOLOGY ANALYZER, MODEL D3 is GKZ.

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 Drew Scientific, 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.

K070704TRILOGY ANALYZER

Related Devices (Code: GKZ)

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.

K260781Yumizen H550HORIBA ABX SASK253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, 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.

↑