FERRITIN RIA KIT
FDA 510(k) clearance K801580 · decided 1980-08-13
Clearance details
- K-number
- K801580
- Device name
- FERRITIN RIA KIT
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-07-10
- Decision date
- 1980-08-13
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- DBF
- Device class
- 2
- Regulation number
- 866.5340
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.