The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Clostridium Difficile Toxin A Enzyme Immunoassay.
| Device ID | K904329 |
| 510k Number | K904329 |
| Device Name: | CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY |
| Classification | Antigen, C. Difficile |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 3093 Bellevue, WA 98009 |
| Contact | Tom Trotter |
| Correspondent | Tom Trotter BAXTER HEALTHCARE CORP. P.O. BOX 3093 Bellevue, WA 98009 |
| Product Code | MCB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-20 |
| Decision Date | 1991-03-12 |