The following data is part of a premarket notification filed by Intelligent Medical Devices, Inc. with the FDA for Imdx C.difficile For Abbott M2000.
| Device ID | K132235 |
| 510k Number | K132235 |
| Device Name: | IMDX C.DIFFICILE FOR ABBOTT M2000 |
| Classification | C. Difficile Toxin Gene Amplification Assay |
| Applicant | Intelligent Medical Devices, Inc. 180 CABOT ST Beverly, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White Intelligent Medical Devices, Inc. 180 CABOT ST Beverly, MA 01915 |
| Product Code | OZN |
| CFR Regulation Number | 866.3130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-18 |
| Decision Date | 2013-10-11 |
| Summary: | summary |