K843745 is an FDA 510(k) clearance for the ADP ANA APPLEZYME. This device is classified as a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM).
Submitted by Apple Diagnostic Products (Pipersille, US). The FDA issued a Cleared decision on October 25, 1984, 30 days after receiving the submission on September 25, 1984.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K843745 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1984 |
| Decision Date | October 25, 1984 |
| Days to Decision | 30 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 |