ENCORE RHEUMATOID FACTOR EIA
FDA 510(k) clearance K924056 · decided 1992-09-25
Clearance details
- K-number
- K924056
- Device name
- ENCORE RHEUMATOID FACTOR EIA
- Applicant
- Clark Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-08-12
- Decision date
- 1992-09-25
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- DHR
- Device class
- 2
- Regulation number
- 866.5775
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Blairstown, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.