The following data is part of a premarket notification filed by Apple Diagnostic Products with the FDA for Adpifa Test For Antibodies To Toxoplasma Gondii.
| Device ID | K844287 |
| 510k Number | K844287 |
| Device Name: | ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII |
| Classification | Antigens, If, Toxoplasma Gondii |
| 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 | GLZ |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-05 |
| Decision Date | 1985-01-07 |