The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Autoantibody Screen Test System.
| Device ID | K831358 |
| 510k Number | K831358 |
| Device Name: | AUTOANTIBODY SCREEN TEST SYSTEM |
| Classification | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | ZEUS SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DBM |
| CFR Regulation Number | 866.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-26 |
| Decision Date | 1983-06-15 |