IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5
FDA 510(k) clearance K990886 · decided 1999-04-06
Clearance details
- K-number
- K990886
- Device name
- IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-17
- Decision date
- 1999-04-06
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- DCK
- Device class
- 2
- Regulation number
- 866.5270
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.