FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GENTIAN CYSTATIN C IMMUNOASSAY
K Number: K071388
·
Decision Nov 6, 2007
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
21
Applicant Total
2
Review Days
172
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Basic Information
- Device Name
- GENTIAN CYSTATIN C IMMUNOASSAY
- K Number
- K071388
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gentian AS
- Date Received
- May 18, 2007
- Decision Date
- November 6, 2007
- Product Code
- NDY
- 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 |
|---|---|---|---|
| NDY | Test, Cystatin C | FDA class 2 | Clinical Chemistry |
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Other Clearances by Gentian AS
| K Number | Device Name | ||
|---|---|---|---|
| K081875 | GENTIAN CYSTATIN C IMMUNOASSAY | Aug 20, 2008 | Substantially Equivalent |