CA 125 II CALCHECK
FDA 510(k) clearance K003967 · decided 2001-01-12
Clearance details
- K-number
- K003967
- Device name
- CA 125 II CALCHECK
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-12-22
- Decision date
- 2001-01-12
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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.
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