FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM
K Number: K120042
·
Decision May 22, 2012
Classifications
1
FEI Numbers
67
Registration Numbers
68
Same Product Code
72
Applicant Total
123
Review Days
138
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Basic Information
- Device Name
- TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM
- K Number
- K120042
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Taidoc Technology Corporation
- Date Received
- January 5, 2012
- Decision Date
- May 22, 2012
- Product Code
- LFR
- 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 |
|---|---|---|---|
| LFR | Glucose Dehydrogenase, Glucose | FDA class 2 | Clinical Chemistry |
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