Systemic Lupus Erythermatosus Anti-N-Dna
FDA 510(k) K821097 · Icl Scientific
510(k) numberK821097
Submission
- Device name
- Systemic Lupus Erythermatosus Anti-N-Dna
- Applicant
- Icl Scientific
Walker, MI, US - Received
- April 20, 1982
- Decision date
- May 5, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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| K822346 | Histimune Enzyme-Ana TestLJM · Traditional | 10/08/1982SE |
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| K821374 | Enzymune-Test InsulinCFP · Traditional | 05/28/1982SE |
Questions and answers
When was Systemic Lupus Erythermatosus Anti-N-Dna cleared by the FDA?
Systemic Lupus Erythermatosus Anti-N-Dna (K821097) received a 510(k) decision of Substantially Equivalent on May 5, 1982, 15 days after the submission was received.