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)

VTEC-RPLA SEIKEN

K-Number: K981734 · 1998-09-22

ApplicantDenka Seiken'S
Decision Date1998-09-22
Product CodeGNA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VTEC-RPLA SEIKEN is the device name listed in this FDA 510(k) record. The listed applicant is Denka Seiken'S. It received FDA 510(k) clearance on 1998-09-22 under 510(k) number K981734. The device is classified under product code GNA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VTEC-RPLA SEIKEN?

VTEC-RPLA SEIKEN is a medical device that received FDA 510(k) clearance on 1998-09-22. The listed applicant is Denka Seiken'S. The 510(k) number is K981734.

When did VTEC-RPLA SEIKEN receive FDA 510(k) clearance?

VTEC-RPLA SEIKEN received FDA 510(k) clearance on 1998-09-22, under 510(k) number K981734.

Who is the listed applicant for VTEC-RPLA SEIKEN?

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

What is the FDA product code for VTEC-RPLA SEIKEN?

The FDA product code for VTEC-RPLA SEIKEN is GNA.

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 Denka Seiken'S 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.

K011400MRSA-SCREENK013359LP(A)-LATEX SEIKEN ASSAY KITK011958CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT

Related Devices (Code: GNA)

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.

K071799MODIFICATION TO BIOSTAR OIA SHIGATOXIverness Medical Professional DiagnosticsK031367DUOPATH VEROTOXINS GLISA TESTEmd Chemicals, Inc.K993401DRYSPOT E.COLI 0157 KITOxoid , Ltd.K962028WELLCOLEX E-COLI OI57 ZC60Murex Diagnostics, Inc.K953362PREMIER EHECMeridian Diagnostics, Inc.K950167PREMIER EHECMeridian Diagnostics, 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.

↑