The following data is part of a premarket notification filed by Diasorin Molecular Llc with the FDA for Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack.
| Device ID | K183223 |
| 510k Number | K183223 |
| Device Name: | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack |
| Classification | Bordetella Pertussis Dna Assay System |
| Applicant | DiaSorin Molecular LLC 11331 Valley View Street Cypress, CA 90630 |
| Contact | Sharon Young |
| Correspondent | Sharon Young DiaSorin Molecular LLC 11331 Valley View Street Cypress, CA 90630 |
| Product Code | OZZ |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-20 |
| Decision Date | 2018-12-19 |