FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM
K Number: K110074
·
Decision May 25, 2012
Classifications
1
FEI Numbers
168
Registration Numbers
169
Same Product Code
507
Applicant Total
60
Review Days
501
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Basic Information
- Device Name
- HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM
- K Number
- K110074
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Health & Life Co., Ltd.
- Date Received
- January 10, 2011
- Decision Date
- May 25, 2012
- Product Code
- NBW
- 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 |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | FDA class 2 | Clinical Chemistry |
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