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FDA 510(k)

inui In-Home Urine Analysis Test System

K-Number: K180356 · 2018-05-25

ApplicantScanadu, Inc.
Decision Date2018-05-25
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

inui In-Home Urine Analysis Test System is a medical device manufactured by Scanadu, Inc.. It received FDA 510(k) clearance on 2018-05-25 under approval number K180356. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the inui In-Home Urine Analysis Test System?

inui In-Home Urine Analysis Test System is a medical device that received FDA 510(k) clearance on 2018-05-25. It is manufactured by Scanadu, Inc.. The 510(k) number is K180356.

When was inui In-Home Urine Analysis Test System approved by the FDA?

inui In-Home Urine Analysis Test System received FDA 510(k) clearance on 2018-05-25, under approval number K180356.

What company makes inui In-Home Urine Analysis Test System?

inui In-Home Urine Analysis Test System is manufactured by Scanadu, Inc..

What is the FDA product code for inui In-Home Urine Analysis Test System?

The FDA product code for inui In-Home Urine Analysis Test System is JIL.

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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)

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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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