FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION
K Number: K101204
·
Decision Aug 31, 2011
Classifications
1
FEI Numbers
145
Registration Numbers
145
Same Product Code
399
Applicant Total
20
Review Days
488
Basic Information
- Device Name
- MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION
- K Number
- K101204
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- APEX BIOTECHNOLOGY CORP.
- Date Received
- April 30, 2010
- Decision Date
- August 31, 2011
- Product Code
- CGA
- 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | Clinical Chemistry |
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