WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY
FDA 510(k) clearance K041155 · decided 2004-10-14
Clearance details
- K-number
- K041155
- Device name
- WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY
- Applicant
- Stanbio Laboratory
- Decision
- Substantially Equivalent
- Date received
- 2004-05-03
- Decision date
- 2004-10-14
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- DCK
- Device class
- 2
- Regulation number
- 866.5270
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Boerne, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.