FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM
K Number: K141914
·
Decision Apr 15, 2015
Classifications
1
FEI Numbers
168
Registration Numbers
169
Same Product Code
507
Applicant Total
9
Review Days
274
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Basic Information
- Device Name
- PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM
- K Number
- K141914
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ok Biotech Co., Ltd.
- Date Received
- July 15, 2014
- Decision Date
- April 15, 2015
- 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 Ok Biotech Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K213061 | SuperCheck Pro Blood Glucose Monitoring System | Oct 7, 2022 | Substantially Equivalent |
| K162430 | UniStrip1 Generic Blood Glucose Test Strips | Jan 19, 2017 | Substantially Equivalent |
| K160038 | UniStrip1 Generic Blood Glucose Test Strips | Jul 29, 2016 | Substantially Equivalent |
| K152599 | PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System | Jul 20, 2016 | Substantially Equivalent |
| K142785 | PRODIGY iConnect Blood Glucose Monitoring System | Dec 17, 2015 | Substantially Equivalent |
| K132633 | OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM | Aug 14, 2014 | Substantially Equivalent |
| K090609 | OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM | Feb 4, 2010 | Substantially Equivalent |
| K063026 | OK METER BLOOD GLUCOSE MONITORING SYSTEM | Feb 9, 2007 | Substantially Equivalent |