The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Antinuclear Antibody (ana) Test System.
| Device ID | K897025 |
| 510k Number | K897025 |
| Device Name: | ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Contact | Donald R Tourville |
| Correspondent | Donald R Tourville ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-19 |
| Decision Date | 1990-01-02 |