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 |