FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181
K Number: K080435
·
Decision Sep 5, 2008
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
234
Applicant Total
3
Review Days
199
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Basic Information
- Device Name
- OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181
- K Number
- K080435
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1110
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Olympus Life Science Research Europa GmbH (Europa)
- Date Received
- February 19, 2008
- Decision Date
- September 5, 2008
- Product Code
- CIG
- 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | FDA class 2 | Clinical Chemistry |
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