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)

ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION

K-Number: K770869 · 1977-06-02

ApplicantGeometric Data, Div. Smithkline Corp.
Decision Date1977-06-02
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Geometric Data, Div. Smithkline Corp.. It received FDA 510(k) clearance on 1977-06-02 under 510(k) number K770869. 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 ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION?

ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION is a medical device that received FDA 510(k) clearance on 1977-06-02. The listed applicant is Geometric Data, Div. Smithkline Corp.. The 510(k) number is K770869.

When did ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION receive FDA 510(k) clearance?

ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION received FDA 510(k) clearance on 1977-06-02, under 510(k) number K770869.

Who is the listed applicant for ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION?

The FDA 510(k) record lists Geometric Data, Div. Smithkline Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION?

The FDA product code for ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION 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 Geometric Data, Div. Smithkline Corp. 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.

K841852AUTOLYZER 800K811534HEMASPINNERK791041HEMATRAK ABNORMAL RECOGNITIONK791108CONTEXT FILTERK790816HEMATRAK MODEL 480K790042STAIN, HEMASTAIN RETIC

View all 18 devices →

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.

↑