2 devices · 1 company · 2022 to 2023
Product code JIR: Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
2 devices under product code JIR, 2022 to 2023, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.). 21 CFR 862.1645, Class I. MAUDE held 44 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Minuteful-kidney testK222921 · 510(k) | Healthy.io Ltd. | Clinical Chemistry | database entry | |
| Minuteful - kidney testK210069 · 510(k) | Healthy.io Ltd. | Clinical Chemistry | database entry |
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