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)

PRINTER, TEK PRO TEK TALLY II

K-Number: K782050 · 1979-01-03

ApplicantTekpro
Decision Date1979-01-03
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PRINTER, TEK PRO TEK TALLY II is the device name listed in this FDA 510(k) record. The listed applicant is Tekpro. It received FDA 510(k) clearance on 1979-01-03 under 510(k) number K782050. 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 PRINTER, TEK PRO TEK TALLY II?

PRINTER, TEK PRO TEK TALLY II is a medical device that received FDA 510(k) clearance on 1979-01-03. The listed applicant is Tekpro. The 510(k) number is K782050.

When did PRINTER, TEK PRO TEK TALLY II receive FDA 510(k) clearance?

PRINTER, TEK PRO TEK TALLY II received FDA 510(k) clearance on 1979-01-03, under 510(k) number K782050.

Who is the listed applicant for PRINTER, TEK PRO TEK TALLY II?

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

What is the FDA product code for PRINTER, TEK PRO TEK TALLY II?

The FDA product code for PRINTER, TEK PRO TEK TALLY II 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 Tekpro 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.

K792306RH VIEWBOX

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.

↑