FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇼 Taiwan
TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System
K Number: K173345
·
Decision May 4, 2018
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
23
Applicant Total
123
Review Days
192
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Basic Information
- Device Name
- TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System
- K Number
- K173345
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1435
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Taidoc Technology Corporation
- Date Received
- October 24, 2017
- Decision Date
- May 4, 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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