K821097Substantially Equivalent
Systemic Lupus Erythermatosus Anti-N-DNA
Icl Scientific, Walker MI / Traditional, Substantially Equivalent
K821097 is the FDA 510(k) clearance record for SYSTEMIC LUPUS ERYTHERMATOSUS ANTI-N-DNA, cleared for Icl Scientific on . FDA records list 48 510(k) clearances for Icl Scientific, from to . As of , FDA records show no recalls naming K821097.
Clearance record
- Decision date
- Received
- (15 days to decision)
- Review panel
- Unknown
- Applicant
- Icl Scientific 4221 Richmond Rd., NW, Walker MI
- Third party review
- No
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