The following data is part of a premarket notification filed by Apotex Scientific, Inc. with the FDA for Ana Profile I.
| Device ID | K932424 |
| 510k Number | K932424 |
| Device Name: | ANA PROFILE I |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | APOTEX SCIENTIFIC, INC. 2100 RD. TO SIX FLAGS EAST Arlington, TX 76011 |
| Contact | Ben Card |
| Correspondent | Ben Card APOTEX SCIENTIFIC, INC. 2100 RD. TO SIX FLAGS EAST Arlington, TX 76011 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-19 |
| Decision Date | 1993-08-10 |