FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
GLUCOCARD® W onyx Blood Glucose Monitoring System
K Number: K183306
·
Decision Apr 10, 2019
Classifications
1
FEI Numbers
168
Registration Numbers
169
Same Product Code
507
Applicant Total
6
Review Days
133
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Basic Information
- Device Name
- GLUCOCARD® W onyx Blood Glucose Monitoring System
- K Number
- K183306
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arkray Factory, Inc.
- Date Received
- November 28, 2018
- Decision Date
- April 10, 2019
- 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 Arkray Factory, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K170064 | GLUCOCARD W Blood Glucose Monitoring System | Aug 16, 2017 | Substantially Equivalent |
| K162822 | ADAMS A1c HA-8180V, CALIBRATOR 80 | Jun 29, 2017 | Substantially Equivalent |
| K142336 | GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System | Sep 17, 2014 | Substantially Equivalent |
| K142035 | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM | Sep 5, 2014 | Substantially Equivalent |
| K124021 | ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM | Jun 30, 2014 | Substantially Equivalent |