OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN
FDA 510(k) clearance K081615 · decided 2009-03-18
Clearance details
- K-number
- K081615
- Device name
- OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN
- Applicant
- Olympus America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-06-09
- Decision date
- 2009-03-18
- Days to decision
- 282 days
- Clearance type
- Traditional
- Product code
- DHX
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- 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.