FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT
K Number: K953520
·
Decision Aug 24, 1995
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
143
Applicant Total
145
Review Days
28
Basic Information
- Device Name
- OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT
- K Number
- K953520
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5775
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- OLYMPUS AMERICA, INC.
- Date Received
- July 27, 1995
- Decision Date
- August 24, 1995
- Product Code
- DHR
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DHR | System, Test, Rheumatoid Factor | FDA class 2 | Immunology |
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