The following data is part of a premarket notification filed by Zeus Technologies with the FDA for Indirect Fluorescent Antibody Myco.
| Device ID | K840012 |
| 510k Number | K840012 |
| Device Name: | INDIRECT FLUORESCENT ANTIBODY MYCO |
| Classification | Antisera, Fluorescent, All, Mycoplasma Spp. |
| Applicant | ZEUS TECHNOLOGIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GRZ |
| CFR Regulation Number | 866.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-04 |
| Decision Date | 1984-02-27 |