LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER
FDA 510(k) clearance K022758 · decided 2002-09-17
Clearance details
- K-number
- K022758
- Device name
- LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER
- Applicant
- Cliniqa Corporation
- Decision
- Substantially Equivalent
- Date received
- 2002-08-20
- Decision date
- 2002-09-17
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- 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.