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FDA 510(k)

ACR LAB Urine Analysis Test System

K-Number: K182384 · 2019-07-26

ApplicantHealthy.Io, Ltd.
Decision Date2019-07-26
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACR LAB Urine Analysis Test System is a medical device manufactured by Healthy.Io, Ltd.. It received FDA 510(k) clearance on 2019-07-26 under approval number K182384. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACR LAB Urine Analysis Test System?

ACR LAB Urine Analysis Test System is a medical device that received FDA 510(k) clearance on 2019-07-26. It is manufactured by Healthy.Io, Ltd.. The 510(k) number is K182384.

When was ACR LAB Urine Analysis Test System approved by the FDA?

ACR LAB Urine Analysis Test System received FDA 510(k) clearance on 2019-07-26, under approval number K182384.

What company makes ACR LAB Urine Analysis Test System?

ACR LAB Urine Analysis Test System is manufactured by Healthy.Io, Ltd..

What is the FDA product code for ACR LAB Urine Analysis Test System?

The FDA product code for ACR LAB Urine Analysis Test System is JFY.

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41712188 A Simulation-Based Root Cause Analysis of Pediatric Medication Dosing Errors in Emergency Medical Services. Prehospital emergency care (2026) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Healthy.Io, Ltd.

K173327DIP/U.S. Urine Analysis Test System K210069Minuteful - kidney test K222921Minuteful-kidney test

Related Devices (Code: JFY)

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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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