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FDA 510(k)

INNOFLOUR GENTAMICIN

K-Number: K841865 · 1984-05-31

ApplicantInnotron Diagnostics
Decision Date1984-05-31
Product CodeLCQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INNOFLOUR GENTAMICIN is the device name listed in this FDA 510(k) record. The listed applicant is Innotron Diagnostics. It received FDA 510(k) clearance on 1984-05-31 under 510(k) number K841865. 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 INNOFLOUR GENTAMICIN?

INNOFLOUR GENTAMICIN is a medical device that received FDA 510(k) clearance on 1984-05-31. The listed applicant is Innotron Diagnostics. The 510(k) number is K841865.

When did INNOFLOUR GENTAMICIN receive FDA 510(k) clearance?

INNOFLOUR GENTAMICIN received FDA 510(k) clearance on 1984-05-31, under 510(k) number K841865.

Who is the listed applicant for INNOFLOUR GENTAMICIN?

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

What is the FDA product code for INNOFLOUR GENTAMICIN?

The FDA product code for INNOFLOUR GENTAMICIN 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 Innotron Diagnostics 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.

K850629INNOFLUOR THEOPHYLLINEK844721INNOFLUOR PRIMIDONEK841866INNOFLOUR TOBRAMYCINK841707INNOFLUOR PHENOBARBITALK841706INNOFLUOR PHENYTOIN

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-RadK955569INNOFLUOR GENTAMICIN ASSAY SYSTEMOxis Intl., Inc.K945523COBAS(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 Laboratories

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.

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