The following data is part of a premarket notification filed by Ivd Research, Inc. with the FDA for C. Difficile Toxin A + B Fecal Antigen Detection Microwell Elisa Kit Model; Cdiff-96.
| Device ID | K032897 |
| 510k Number | K032897 |
| Device Name: | C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96 |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | IVD RESEARCH, INC. 5909 SEA LION PLACE, SUITE D Carlsbad, CA 92008 |
| Contact | Dave Lambillotte |
| Correspondent | Dave Lambillotte IVD RESEARCH, INC. 5909 SEA LION PLACE, SUITE D Carlsbad, CA 92008 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-17 |
| Decision Date | 2004-05-27 |