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FDA 510(k)

URINE COLLECTION KIT/DEVICE

K-Number: K913330 · 1991-08-26

ApplicantMedical Implements, Inc.
Decision Date1991-08-26
Product CodeKHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URINE COLLECTION KIT/DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Implements, Inc.. It received FDA 510(k) clearance on 1991-08-26 under 510(k) number K913330. The device is classified under product code KHP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINE COLLECTION KIT/DEVICE?

URINE COLLECTION KIT/DEVICE is a medical device that received FDA 510(k) clearance on 1991-08-26. The listed applicant is Medical Implements, Inc.. The 510(k) number is K913330.

When did URINE COLLECTION KIT/DEVICE receive FDA 510(k) clearance?

URINE COLLECTION KIT/DEVICE received FDA 510(k) clearance on 1991-08-26, under 510(k) number K913330.

Who is the listed applicant for URINE COLLECTION KIT/DEVICE?

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

What is the FDA product code for URINE COLLECTION KIT/DEVICE?

The FDA product code for URINE COLLECTION KIT/DEVICE is KHP.

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 Medical Implements, 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.

K933401THE BUCK

Related Devices (Code: KHP)

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.

K130113PICCOLO LACTATE TEST SYSTEMAbaxis, Inc.K113216RAPIDPOINT 500 BLOOD GAS ANALYERSiemens Healthcare DiagnosticsK112955NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEMNova Biomedical CorporationK112430I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGEAbbott Pont of Care, Inc.K100602NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPSNova Biomedical Corp.K093297EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBEEpocal, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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