FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
K Number: K181024
·
Decision May 23, 2018
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
80
Applicant Total
4
Review Days
35
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Basic Information
- Device Name
- DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
- K Number
- K181024
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1340
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DFI Co., Ltd.
- Date Received
- April 18, 2018
- Decision Date
- May 23, 2018
- Product Code
- JIL
- 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 |
|---|---|---|---|
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | FDA class 2 | Clinical Chemistry |
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