FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
GAL-1A BLOOD GLUCOSE MONITORING SYSTEM
K Number: K113208
·
Decision Jan 26, 2012
Classifications
1
FEI Numbers
145
Registration Numbers
145
Same Product Code
399
Applicant Total
20
Review Days
86
Basic Information
- Device Name
- GAL-1A BLOOD GLUCOSE MONITORING SYSTEM
- K Number
- K113208
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- APEX BIOTECHNOLOGY CORP.
- Date Received
- November 1, 2011
- Decision Date
- January 26, 2012
- 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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