The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Fta-abs Test System.
| Device ID | K781403 |
| 510k Number | K781403 |
| Device Name: | FTA-ABS TEST SYSTEM |
| Classification | Anti-human Globulin, Fta-abs Test |
| Applicant | ZEUS SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GMS |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-15 |
| Decision Date | 1978-08-21 |