The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Bartels Clostridium Difficile Toxin A Enzym Immun.
| Device ID | K913229 |
| 510k Number | K913229 |
| Device Name: | BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | BAXTER DIAGNOSTICS, INC. BARTELS DIAGNOSTICS DIVISION P.O. BOX 3093 Bellevue, WA 98009 |
| Contact | Scott Dennis |
| Correspondent | Scott Dennis BAXTER DIAGNOSTICS, INC. BARTELS DIAGNOSTICS DIVISION P.O. BOX 3093 Bellevue, WA 98009 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-22 |
| Decision Date | 1991-08-29 |