FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URIC ACID
K Number: K981189
·
Decision May 7, 1998
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
30
Applicant Total
883
Review Days
35
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Basic Information
- Device Name
- URIC ACID
- K Number
- K981189
- 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
- April 2, 1998
- Decision Date
- May 7, 1998
- Product Code
- CDO
- 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 |
|---|---|---|---|
| CDO | Acid, Uric, Uricase (U.V.) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
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