The following data is part of a premarket notification filed by Diasorin Molecular Llc with the FDA for Simplexa Congenital Cmv Direct And Simplexa Congenital Cmv Positive Control Pack.
| Device ID | K202755 |
| 510k Number | K202755 |
| Device Name: | Simplexa Congenital CMV Direct And Simplexa Congenital CMV Positive Control Pack |
| Classification | Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection |
| 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 | QDZ |
| CFR Regulation Number | 866.3181 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-21 |
| Decision Date | 2022-11-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816101025842 | K202755 | 000 |
| 20816101025835 | K202755 | 000 |