Chrysalis Intelligence · Sponsors · I-Sens, Inc.

I-Sens, Inc.

Seoul, KR · 6 510(k) clearances

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Total clearances
6
2020-01-17 → 2023-08-10
Last 12 months
0
Product codes
3
Most recent
2023-08-10
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NBW System, Test, Blood Glucose, Over The Counter Class II Clinical Chemistry 4 2023-08-10
QRL — — — 1 2022-11-23
JIN — — — 1 2020-09-09
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2023-08-10 K230625 ReliOn Premier BLU Blood Glucose Monitoring System NBW Class II Clinical Chemistry
2022-11-23 K222656 LDE4 Lancing Device QRL — —
2021-10-05 K201394 CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System NBW Class II Clinical Chemistry
2020-09-09 K201551 KetoSens BT Blood B-Ketone Monitoring System JIN — —
2020-01-24 K192859 CareSens S Clear BT Blood Glucose Monitoring System NBW Class II Clinical Chemistry
2020-01-17 K193590 CareSens S Fit BT Blood Glucose Monitoring System NBW Class II Clinical Chemistry
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence