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FDA 510(k)

URINE SCREENING KITS

K-Number: K780021 · 1978-03-17

ApplicantDiagnostic Culture System
Decision Date1978-03-17
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

URINE SCREENING KITS is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Culture System. It received FDA 510(k) clearance on 1978-03-17 under 510(k) number K780021. 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 URINE SCREENING KITS?

URINE SCREENING KITS is a medical device that received FDA 510(k) clearance on 1978-03-17. The listed applicant is Diagnostic Culture System. The 510(k) number is K780021.

When did URINE SCREENING KITS receive FDA 510(k) clearance?

URINE SCREENING KITS received FDA 510(k) clearance on 1978-03-17, under 510(k) number K780021.

Who is the listed applicant for URINE SCREENING KITS?

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

What is the FDA product code for URINE SCREENING KITS?

The FDA product code for URINE SCREENING KITS 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

Other records listing Diagnostic Culture System 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.

K780022CULTURE MEDIA/ISOLA. PATHO. NEISSERIA

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.K950221MULTIPLE (IZON BLOOD & 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.

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