FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URIC ACID COLORIMETRIC DETERMINATION
K Number: K830679
·
Decision Apr 6, 1983
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
117
Applicant Total
2
Review Days
33
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Basic Information
- Device Name
- URIC ACID COLORIMETRIC DETERMINATION
- K Number
- K830679
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Dow Instruments & Reagents, Inc.
- Date Received
- March 4, 1983
- Decision Date
- April 6, 1983
- 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 |
Similar 510(k) Clearances
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WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA
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Other Clearances by Dow Instruments & Reagents, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K830469 | BILIRUBIN STANDARD-LYOPHILIZED | Mar 24, 1983 | Substantially Equivalent |