EOCENE SYSTEM
FDA 510(k) clearance K090712 · decided 2009-10-02
Clearance details
- K-number
- K090712
- Device name
- EOCENE SYSTEM
- Applicant
- Infopia Co, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-03-18
- Decision date
- 2009-10-02
- Days to decision
- 198 days
- Clearance type
- Special
- Product code
- NBW
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.