FDA 510(k)
FDA class 1
Substantially Equivalent
🇰🇷 South Korea
KetoSens BT Blood B-Ketone Monitoring System
K Number: K201551
·
Decision Sep 9, 2020
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
23
Applicant Total
25
Review Days
92
Basic Information
- Device Name
- KetoSens BT Blood B-Ketone Monitoring System
- K Number
- K201551
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.1435
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- i-SENS, Inc.
- Date Received
- June 9, 2020
- Decision Date
- September 9, 2020
- Product Code
- JIN
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIN), ordered by most recent decision date.
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PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by i-SENS, Inc.
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|---|---|---|---|
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| K192859 | CareSens S Clear BT Blood Glucose Monitoring System | Jan 24, 2020 | Substantially Equivalent |
| K193590 | CareSens S Fit BT Blood Glucose Monitoring System | Jan 17, 2020 | Substantially Equivalent |
| K192220 | ReliOn Premier Classic Blood Glucose Monitoring System | Dec 13, 2019 | Substantially Equivalent |
| K181273 | GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System | Nov 1, 2018 | Substantially Equivalent |
| K180866 | CareSens S Fit Blood Glucose Monitoring System | Aug 31, 2018 | Substantially Equivalent |
| K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System | Apr 13, 2018 | Substantially Equivalent |
| K171480 | NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System | Dec 13, 2017 | Substantially Equivalent |