FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URIC ACID MODEL 3P39
K Number: K102568
·
Decision May 6, 2011
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
117
Applicant Total
857
Review Days
241
Basic Information
- Device Name
- URIC ACID MODEL 3P39
- K Number
- K102568
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ABBOTT LABORATORIES
- Date Received
- September 7, 2010
- Decision Date
- May 6, 2011
- Product Code
- KNK
- 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 |
|---|---|---|---|
| KNK | Acid, Uric, Uricase (Colorimetric) | FDA class 1 | Clinical Chemistry |
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