The following data is part of a premarket notification filed by Apple Diagnostic Products with the FDA for Adp Ana Applezyme.
| Device ID | K843745 |
| 510k Number | K843745 |
| Device Name: | ADP ANA APPLEZYME |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | APPLE DIAGNOSTIC PRODUCTS P.O. BOX 216 Pipersille, PA 18942 |
| Contact | Raj Irukulla |
| Correspondent | Raj Irukulla APPLE DIAGNOSTIC PRODUCTS P.O. BOX 216 Pipersille, PA 18942 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-25 |
| Decision Date | 1984-10-25 |