FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
K Number: K062862
·
Decision Apr 6, 2007
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
117
Applicant Total
145
Review Days
193
Basic Information
- Device Name
- OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
- K Number
- K062862
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- OLYMPUS AMERICA, INC.
- Date Received
- September 25, 2006
- Decision Date
- April 6, 2007
- 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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