OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104
FDA 510(k) clearance K070708 · decided 2007-08-21
Clearance details
- K-number
- K070708
- Device name
- OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104
- Applicant
- Olympus Life & Material Science Europa GmbH (Irish
- Decision
- Substantially Equivalent
- Date received
- 2007-03-14
- Decision date
- 2007-08-21
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- CEC
- Device class
- 2
- Regulation number
- 862.1695
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Co. Clare, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.