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)

INNOFLUOR GENTAMICIN ASSAY SYSTEM

K-Number: K955569 · 1996-02-09

ApplicantOxis Intl., Inc.
Decision Date1996-02-09
Product CodeLCQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INNOFLUOR GENTAMICIN ASSAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Oxis Intl., Inc.. It received FDA 510(k) clearance on 1996-02-09 under 510(k) number K955569. The device is classified under product code LCQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOFLUOR GENTAMICIN ASSAY SYSTEM?

INNOFLUOR GENTAMICIN ASSAY SYSTEM is a medical device that received FDA 510(k) clearance on 1996-02-09. The listed applicant is Oxis Intl., Inc.. The 510(k) number is K955569.

When did INNOFLUOR GENTAMICIN ASSAY SYSTEM receive FDA 510(k) clearance?

INNOFLUOR GENTAMICIN ASSAY SYSTEM received FDA 510(k) clearance on 1996-02-09, under 510(k) number K955569.

Who is the listed applicant for INNOFLUOR GENTAMICIN ASSAY SYSTEM?

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

What is the FDA product code for INNOFLUOR GENTAMICIN ASSAY SYSTEM?

The FDA product code for INNOFLUOR GENTAMICIN ASSAY SYSTEM is LCQ.

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 Oxis Intl., 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.

K972331INNOFLUOR GENTAMICIN ASSAY SYSTEMK972330INNOFLUOR PHENOBARBITAL ASSAY SYSTEMK970510INNOFLOUR TOPIRAMATE REAGENT SETK970509INNOFLOUR CALIBRATOR REAGENT SETK970517INNOFLUOR TOPIRAMATE CONTROL SETK955568INNOFLUOR QUINIDINE ASSAY SYSTEM

View all 11 devices →

Related Devices (Code: LCQ)

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.

K972609VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAMBio-RadK945523COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORSRoche Diagnostic Systems, Inc.K943550GENTAMICIN FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.K905721OPUS GENTAMICINPb Diagnostic Systems, Inc.K904226'TDXFLX ANALYZERAbbott LaboratoriesK894523FPR GENTAMICIN KITColony Laboratories, 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.

↑