OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
FDA 510(k) clearance K041668 · decided 2004-08-19
Clearance details
- K-number
- K041668
- Device name
- OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
- Applicant
- Olympus America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-06-18
- Decision date
- 2004-08-19
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- NQD
- Device class
- 2
- Regulation number
- 866.5270
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Irving, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.