KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System— 510(k) K170463
Substantially EquivalentI-Sens, Inc.
FDA 510(k) clearance K170463 for KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System, Substantially Equivalent on 2018-04-13. Applicant: I-Sens, Inc.. Device class: 1.
Clearance details
- Applicant
- I-Sens, Inc.
- Product code
- Code JIN
- Device class
- Class 1
- Regulation
- 21 CFR 862.1435
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
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Data sourced from openFDA. This site is unofficial and independent of the FDA.