LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS
FDA 510(k) clearance K030074 · decided 2003-01-21
Clearance details
- K-number
- K030074
- Device name
- LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS
- Applicant
- Cliniqa Corporation
- Decision
- Substantially Equivalent
- Date received
- 2003-01-08
- Decision date
- 2003-01-21
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- JIX
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Fallbrook, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.