The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Toxogen.
| Device ID | K981263 |
| 510k Number | K981263 |
| Device Name: | TOXOGEN |
| Classification | Antigens, Iha, Toxoplasma Gondii |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Product Code | GMM |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-07 |
| Decision Date | 1998-08-06 |
| Summary: | summary |