The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas Cdiff Test.
| Device ID | K142422 |
| 510k Number | K142422 |
| Device Name: | Cobas Cdiff Test |
| Classification | C. Difficile Toxin Gene Amplification Assay |
| Applicant | ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DRIVE Pleasanton, CA 94588 -2722 |
| Contact | Wilk Von Gustedt |
| Correspondent | David W. Gates ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DRIVE Pleasanton, CA 94588 -2722 |
| Product Code | OZN |
| CFR Regulation Number | 866.3130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-28 |
| Decision Date | 2015-05-20 |
| Summary: | summary |