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)

MODIFIED RUBAGEN

K-Number: K896433 · 1989-11-29

ApplicantBiokit USA, Inc.
Decision Date1989-11-29
Product CodeLQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFIED RUBAGEN is the device name listed in this FDA 510(k) record. The listed applicant is Biokit USA, Inc.. It received FDA 510(k) clearance on 1989-11-29 under 510(k) number K896433. The device is classified under product code LQN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED RUBAGEN?

MODIFIED RUBAGEN is a medical device that received FDA 510(k) clearance on 1989-11-29. The listed applicant is Biokit USA, Inc.. The 510(k) number is K896433.

When did MODIFIED RUBAGEN receive FDA 510(k) clearance?

MODIFIED RUBAGEN received FDA 510(k) clearance on 1989-11-29, under 510(k) number K896433.

Who is the listed applicant for MODIFIED RUBAGEN?

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

What is the FDA product code for MODIFIED RUBAGEN?

The FDA product code for MODIFIED RUBAGEN is LQN.

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 Biokit USA, 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.

K913467TOXOGENK910541BIOKIT RPRK904310RHEUMAGEN RF T-CONTROLK910539RHEUMAJET RFK910686RHEUMAJET CRPK904311RHEUMAGEN ASO T-CONTROL

View all 16 devices →

Related Devices (Code: LQN)

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.

K031490RUBELLACOLImmunostics Inc.,K970931COPALIS TORC TOTAL ANTIBODY ASSAYSienna Biotech, Inc.K961784COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYSSienna Biotech, Inc.K954920MUREX RUB-EXMurex Diagnostics, Inc.K952544COLORSLIDER RUBELLASeradyn, Inc.K912391RUBALEX, MODIFICATIONOrion Corp.

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.

↑