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FDA 510(k)

DIP/U.S. Urine Analysis Test System

K-Number: K173327 · 2018-07-18

ApplicantHealthy.Io, Ltd.
Decision Date2018-07-18
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIP/U.S. Urine Analysis Test System is the device name listed in this FDA 510(k) record. The listed applicant is Healthy.Io, Ltd.. It received FDA 510(k) clearance on 2018-07-18 under 510(k) number K173327. 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 DIP/U.S. Urine Analysis Test System?

DIP/U.S. Urine Analysis Test System is a medical device that received FDA 510(k) clearance on 2018-07-18. The listed applicant is Healthy.Io, Ltd.. The 510(k) number is K173327.

When did DIP/U.S. Urine Analysis Test System receive FDA 510(k) clearance?

DIP/U.S. Urine Analysis Test System received FDA 510(k) clearance on 2018-07-18, under 510(k) number K173327.

Who is the listed applicant for DIP/U.S. Urine Analysis Test System?

The FDA 510(k) record lists Healthy.Io, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIP/U.S. Urine Analysis Test System?

The FDA product code for DIP/U.S. Urine Analysis Test System is JIL.

Other records listing Healthy.Io, Ltd. 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.

K222921Minuteful-kidney testK210069Minuteful - kidney testK182384ACR LAB Urine Analysis Test System

Related Devices (Code: JIL)

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.

K193514AUTION MAX AX-4060 Urinalysis SystemArkray, Inc.K183432cobas u 601 urinalysis test systemRoche DiagnosticsK180356inui In-Home Urine Analysis Test SystemScanadu, Inc.K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsDFI Co., Ltd.K171521DUS R-50S (Urine Chemistry system)DFI Co., Ltd.K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, 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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