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)

GENTAMICIN CONTROL SERUM

K-Number: K792261 · 1979-12-18

ApplicantHemometrix
Decision Date1979-12-18
Product CodeLAS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

GENTAMICIN CONTROL SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Hemometrix. It received FDA 510(k) clearance on 1979-12-18 under 510(k) number K792261. The device is classified under product code LAS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTAMICIN CONTROL SERUM?

GENTAMICIN CONTROL SERUM is a medical device that received FDA 510(k) clearance on 1979-12-18. The listed applicant is Hemometrix. The 510(k) number is K792261.

When did GENTAMICIN CONTROL SERUM receive FDA 510(k) clearance?

GENTAMICIN CONTROL SERUM received FDA 510(k) clearance on 1979-12-18, under 510(k) number K792261.

Who is the listed applicant for GENTAMICIN CONTROL SERUM?

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

What is the FDA product code for GENTAMICIN CONTROL SERUM?

The FDA product code for GENTAMICIN CONTROL SERUM is LAS.

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 Hemometrix 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.

K800037PLATELET RETENTION (ADHESION) COLUMNSK792263TOBRAMYCIN CONTROL SERUMK792260AMIKACIN LIQUID CONTROL SERUMK792264TOBRAMYCIN LIQUID CONTROL SERUMK792262GENTAMICIN LIQUID CONTROL SERUMK792259AMIKACIN CONTROL SERUM

View all 7 devices →

Related Devices (Code: LAS)

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.

K080459CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLSChromsystems Instruments & Chemicals GmbHK072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELMore DiagnosticsK062942QUANTIMETRIX NICOSURE COTININE URINE CONTROLQuantimetrix Corp.K051074MAS IMMUNOSUPPRESSANT CONTROLSMicrogenics Corp.K040411DRI OXYCODONE ASSAYMicrogenics Corp.K032842MICROGENICS CYCLOSPORINE CONTROL KITMicrogenics 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.

↑