Elecsys CA-125 II assay
FDA 510(k) clearance K143534 · decided 2015-08-06
Clearance details
- K-number
- K143534
- Device name
- Elecsys CA-125 II assay
- Applicant
- Roche Professional Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2014-12-12
- Decision date
- 2015-08-06
- Days to decision
- 237 days
- Clearance type
- Traditional
- Product code
- LTK
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.