FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104
K Number: K070708
·
Decision Aug 21, 2007
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
91
Applicant Total
3
Review Days
160
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Basic Information
- Device Name
- OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104
- K Number
- K070708
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1695
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Olympus Life & Material Science Europa GmbH (Irish
- Date Received
- March 14, 2007
- Decision Date
- August 21, 2007
- Product Code
- CEC
- 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 |
|---|---|---|---|
| CEC | Radioimmunoassay, Free Thyroxine | FDA class 2 | Clinical Chemistry |
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