FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇼 Taiwan
FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System
K Number: K181675
·
Decision Dec 10, 2018
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
2
Applicant Total
123
Review Days
168
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Basic Information
- Device Name
- FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System
- K Number
- K181675
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Taidoc Technology Corporation
- Date Received
- June 25, 2018
- Decision Date
- December 10, 2018
- Product Code
- PTC
- 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 |
|---|---|---|---|
| PTC | Uric Acid Test System For At Home Prescription Use | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PTC), ordered by most recent decision date.
UASure II Blood Uric Acid Monitoring System
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Nova Max Uric Acid Monitoring System
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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