FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇷 Iran
URIC ACID ENZYMATIC COLORIMERIC KIT
K Number: K923503
·
Decision Jul 22, 1993
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
117
Applicant Total
116
Review Days
372
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Basic Information
- Device Name
- URIC ACID ENZYMATIC COLORIMERIC KIT
- K Number
- K923503
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Randox Laboratories, Ltd.
- Date Received
- July 15, 1992
- Decision Date
- July 22, 1993
- 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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