The following data is part of a premarket notification filed by Bionetic Laboratory Products with the FDA for Immunoenzyme Test Sys-detect-igm Anti.
| Device ID | K832900 |
| 510k Number | K832900 |
| Device Name: | IMMUNOENZYME TEST SYS-DETECT-IGM ANTI |
| Classification | Antigens, If, Toxoplasma Gondii |
| Applicant | BIONETIC LABORATORY PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GLZ |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-29 |
| Decision Date | 1983-11-14 |