FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RIGHTEST CONTROL SOLUTION
K Number: K133003
·
Decision Oct 24, 2013
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
492
Applicant Total
21
Review Days
29
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Basic Information
- Device Name
- RIGHTEST CONTROL SOLUTION
- K Number
- K133003
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bionime Corporation
- Date Received
- September 25, 2013
- Decision Date
- October 24, 2013
- Product Code
- JJX
- 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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|---|---|---|---|
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| K190564 | Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB | Jun 2, 2019 | Substantially Equivalent |
| K173638 | Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus | Aug 17, 2018 | Substantially Equivalent |
| K173139 | Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus | Jun 19, 2018 | Substantially Equivalent |
| K170143 | GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, | Jul 6, 2017 | Substantially Equivalent |
| K161790 | iGlucose Blood Glucose Monitoring System | May 2, 2017 | Substantially Equivalent |
| K140210 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720 | Aug 22, 2014 | Substantially Equivalent |
| K123008 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN | Jan 25, 2013 | Substantially Equivalent |