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)

LUMAC'S BACTERIURIA SCREENING KIT

K-Number: K810746 · 1981-07-31

ApplicantLumac
Decision Date1981-07-31
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LUMAC'S BACTERIURIA SCREENING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Lumac. It received FDA 510(k) clearance on 1981-07-31 under 510(k) number K810746. The device is classified under product code JXA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMAC'S BACTERIURIA SCREENING KIT?

LUMAC'S BACTERIURIA SCREENING KIT is a medical device that received FDA 510(k) clearance on 1981-07-31. The listed applicant is Lumac. The 510(k) number is K810746.

When did LUMAC'S BACTERIURIA SCREENING KIT receive FDA 510(k) clearance?

LUMAC'S BACTERIURIA SCREENING KIT received FDA 510(k) clearance on 1981-07-31, under 510(k) number K810746.

Who is the listed applicant for LUMAC'S BACTERIURIA SCREENING KIT?

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

What is the FDA product code for LUMAC'S BACTERIURIA SCREENING KIT?

The FDA product code for LUMAC'S BACTERIURIA SCREENING KIT is JXA.

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

Related Devices (Code: JXA)

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.

K011043OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)OsmetechK981084URISCREENDiatech Diagnostics,Inc.K972676URINE SCREENING DEVICECombact Diagnostic Systems , Ltd.K952246TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KITTri-Tech, Inc.K950257MULTIPLE (IZON DBS & URINE COLLECTION KIT)Izon Business Products, Inc.K950246MULTIPLE (IZON URINE COLLECTION KIT)Izon Business Products, 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.

↑