LPIA-FERRITIN ASSAY
FDA 510(k) clearance K924186 · decided 1992-12-23
Clearance details
- K-number
- K924186
- Device name
- LPIA-FERRITIN ASSAY
- Applicant
- Seradyn, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-08-20
- Decision date
- 1992-12-23
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- DEF
- Device class
- 1
- Regulation number
- 866.5425
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.