FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇼 Taiwan
KET-1 Blood Ketone Monitoring System
K Number: K182593
·
Decision Dec 18, 2018
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
23
Applicant Total
35
Review Days
89
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Basic Information
- Device Name
- KET-1 Blood Ketone Monitoring System
- K Number
- K182593
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1435
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Apex BioTechnology Corp.
- Date Received
- September 20, 2018
- Decision Date
- December 18, 2018
- 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 |
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PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
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| K213887 | GAL-1A Plus Blood Glucose Monitoring System | Mar 29, 2022 | Substantially Equivalent |
| K201880 | MultiSure GK Link Blood Glucose and Ketone Monitoring System | Oct 15, 2021 | Substantially Equivalent |
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| K182992 | BGM014 Blood Glucose Monitoring System | Nov 28, 2018 | Substantially Equivalent |
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