SYSTEMIC LUPUS ERYTHERMATOSUS ANTI-N-DNA
FDA 510(k) clearance K821097 · decided 1982-05-05
Clearance details
- K-number
- K821097
- Device name
- SYSTEMIC LUPUS ERYTHERMATOSUS ANTI-N-DNA
- Applicant
- Icl Scientific
- Decision
- Substantially Equivalent
- Date received
- 1982-04-20
- Decision date
- 1982-05-05
- Days to decision
- 15 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.