FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPUS PREALBUMIN CALIBRATOR, ODR3029
K Number: K032285
·
Decision Aug 21, 2003
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
244
Applicant Total
149
Review Days
28
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Basic Information
- Device Name
- OLYMPUS PREALBUMIN CALIBRATOR, ODR3029
- K Number
- K032285
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Olympus America, Inc.
- Date Received
- July 24, 2003
- Decision Date
- August 21, 2003
- Product Code
- JIT
- 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 |
|---|---|---|---|
| JIT | Calibrator, Secondary | FDA class 2 | Clinical Chemistry |
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