The following data is part of a premarket notification filed by Diasorin Molecular Llc with the FDA for Simplexa Vzv Direct, Simplexa Vzv Positive Control Pack.
| Device ID | K190219 |
| 510k Number | K190219 |
| Device Name: | Simplexa VZV Direct, Simplexa VZV Positive Control Pack |
| Classification | Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection 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 | PLO |
| CFR Regulation Number | 866.3970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-04 |
| Decision Date | 2019-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816101025781 | K190219 | 000 |
| 20816101025774 | K190219 | 000 |