K822346 is an FDA 510(k) clearance for the HISTIMUNE ENZYME-ANA TEST. This device is classified as a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II - Special Controls, product code LJM).
Submitted by Icl Scientific (Mchenry, US). The FDA issued a Cleared decision on October 8, 1982, 63 days after receiving the submission on August 6, 1982.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K822346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 1982 |
| Decision Date | October 08, 1982 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | LJM — Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |