The following data is part of a premarket notification filed by Immuno-diagnostic Products, Inc. with the FDA for Toxoplasmosis Test Kit.
| Device ID | K811562 |
| 510k Number | K811562 |
| Device Name: | TOXOPLASMOSIS TEST KIT |
| Classification | Antigens, If, Toxoplasma Gondii |
| Applicant | IMMUNO-DIAGNOSTIC PRODUCTS, INC. 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 | 1981-06-03 |
| Decision Date | 1981-07-16 |