FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
MultiSure GK Link Blood Glucose and Ketone Monitoring System
K Number: K201880
·
Decision Oct 15, 2021
Classifications
1
FEI Numbers
168
Registration Numbers
169
Same Product Code
507
Applicant Total
35
Review Days
465
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Basic Information
- Device Name
- MultiSure GK Link Blood Glucose and Ketone Monitoring System
- K Number
- K201880
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Apex BioTechnology Corp.
- Date Received
- July 7, 2020
- Decision Date
- October 15, 2021
- 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 Apex BioTechnology Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K242209 | UASure II Blood Uric Acid Monitoring System | Apr 4, 2025 | Substantially Equivalent |
| K222234 | GlucoSure ADVANCE Link Blood Glucose Monitoring System | Dec 21, 2022 | Substantially Equivalent |
| K220421 | BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System | Nov 4, 2022 | Substantially Equivalent |
| K212140 | GlucoSure Link Blood Glucose Monitoring System | Aug 25, 2022 | Substantially Equivalent |
| K202534 | MTM301 Blood Glucose and Ketone Monitoring System | Apr 6, 2022 | Substantially Equivalent |
| K213887 | GAL-1A Plus Blood Glucose Monitoring System | Mar 29, 2022 | Substantially Equivalent |
| K202885 | GlucoSure HT Plus Blood Glucose Monitoring System | Sep 15, 2021 | Substantially Equivalent |
| K182593 | KET-1 Blood Ketone Monitoring System | Dec 18, 2018 | Substantially Equivalent |
| K182992 | BGM014 Blood Glucose Monitoring System | Nov 28, 2018 | Substantially Equivalent |
| K170267 | BGM009 Plus Blood Glucose Monitoring System | Mar 9, 2017 | Substantially Equivalent |