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)

MULTI-STRIP

K-Number: K901228 · 1990-05-07

ApplicantBellhouse Medical, Inc.
Decision Date1990-05-07
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MULTI-STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Bellhouse Medical, Inc.. It received FDA 510(k) clearance on 1990-05-07 under 510(k) number K901228. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTI-STRIP?

MULTI-STRIP is a medical device that received FDA 510(k) clearance on 1990-05-07. The listed applicant is Bellhouse Medical, Inc.. The 510(k) number is K901228.

When did MULTI-STRIP receive FDA 510(k) clearance?

MULTI-STRIP received FDA 510(k) clearance on 1990-05-07, under 510(k) number K901228.

Who is the listed applicant for MULTI-STRIP?

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

What is the FDA product code for MULTI-STRIP?

The FDA product code for MULTI-STRIP is FKX.

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 Bellhouse Medical, 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.

K905022AQUA-GARD WATERPROOF WOUND PATCHK862302BLOOD PLATELET ASSAY METHOD & APPARATUS

Related Devices (Code: FKX)

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.

K250523Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)Simergent, LLCK243371Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1Byonyks Pvt, Ltd.K220935Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone AppIren-Medical, Ltd.K222318Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLCK212522Lilliput APD SystemFresenius Medical Care Renal Therapies Group, LLCK212658CloudCath Peritoneal Dialysis Drain Set Monitoring SystemCloudcath

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.

↑