FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEPHROCHECK Test System
K Number: K171482
·
Decision Nov 16, 2017
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
3
Review Days
181
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Basic Information
- Device Name
- NEPHROCHECK Test System
- K Number
- K171482
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1220
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Astute Medical, Inc.
- Date Received
- May 19, 2017
- Decision Date
- November 16, 2017
- Product Code
- PIG
- 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 |
|---|---|---|---|
| PIG | Acute Kidney Injury Test System | FDA class 2 | Clinical Chemistry |
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