1 device · 1 company · 2018
Product code JIL: Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
1 device under product code JIL, 2018, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Method, Enzymatic, Glucose (Urinary, Non-Quantitative). 21 CFR 862.1340, Class II. MAUDE held 609 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.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| DIP/U.S. Urine Analysis Test SystemK173327 · 510(k) | Healthy.io Ltd | Clinical Chemistry | database entry |
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