FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
K Number: K003721
·
Decision Dec 18, 2000
Classifications
1
FEI Numbers
174
Registration Numbers
174
Same Product Code
207
Applicant Total
149
Review Days
14
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Basic Information
- Device Name
- MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
- K Number
- K003721
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.2160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Olympus America, Inc.
- Date Received
- December 4, 2000
- Decision Date
- December 18, 2000
- Product Code
- JJE
- 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 |
|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | FDA class 1 | Clinical Chemistry |
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