FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
K Number: K103044
·
Decision Feb 10, 2012
Classifications
1
FEI Numbers
177
Registration Numbers
178
Same Product Code
506
Applicant Total
6
Review Days
484
Basic Information
- Device Name
- AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
- K Number
- K103044
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BESTGEN BIOTECH CORP.
- Date Received
- October 14, 2010
- Decision Date
- February 10, 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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Other Clearances by BESTGEN BIOTECH CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K103230 | AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION | Apr 24, 2012 | Substantially Equivalent |
| K103116 | AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM | Mar 13, 2012 | Substantially Equivalent |
| K100437 | AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION | Jan 12, 2012 | Substantially Equivalent |
| K090389 | AP-1000 BLOOD GLUCOSE MONITORING SYSTEM | Jul 14, 2009 | Substantially Equivalent |
| K072274 | MAJOR III BLOOD GLUCOSE MONITORING SYSTEM | Feb 29, 2008 | Substantially Equivalent |