The following data is part of a premarket notification filed by Focus Diagnostics, Inc.: Dba Diasorin Molecular Llc with the FDA for Simplexa C. Difficile Direct; Simplexa C. Difficile Positive Control Pack.
| Device ID | K163085 |
| 510k Number | K163085 |
| Device Name: | Simplexa C. Difficile Direct; Simplexa C. Difficile Positive Control Pack |
| Classification | C. Difficile Toxin Gene Amplification Assay |
| Applicant | Focus Diagnostics, Inc.: DBA DiaSorin Molecular LLC 11331 Valley View Street Cypress, CA 90630 |
| Contact | Irene M. Guzman |
| Correspondent | Irene M. Guzman Focus Diagnostics, Inc.: DBA DiaSorin Molecular LLC 11331 Valley View Street Cypress, CA 90630 |
| Product Code | OZN |
| CFR Regulation Number | 866.3130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-03 |
| Decision Date | 2017-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816101025613 | K163085 | 000 |
| 20816101025606 | K163085 | 000 |
| 20816101025590 | K163085 | 000 |